In terms of safety, Favipiravir has been approved by PMDA of Japan in 2014 and there is no obvious adverse reaction found since marketing. In the clinical study for the treatment of COVID-19(Corona Virus Disease 2019), no obvious adverse reaction has been found.

In terms of efficacy, the Third People’s Hospital of Shenzhen carried out an efficacy and safety study for the treatment of COVID-19 with Favipiravir combined with interferon. This study has enrolled 80 subjects including 35 subjects of Favipiravir group and 45 subjects of control group. The study result shows, in the aspect of transforming the viral nucleic acid into negative, the median time of Favipiravir group (4 days) has been shortened compared with control group (11 days) with a significant difference. In terms of improvement in chest imaging, the improvement rates of Favipiravir group and control group are 91.43% and 62.22% respectively.

Zhongnan Hospital of Wuhan University led a multi-center, randomized, open and positive parallel controlled clinical study of Favipiravir for the treatment of COVID-19, and has enrolled 120 subjects of each group and observed clinical treatment. This clinical study displayed the therapeutic efficacy of treatment group on COVID-19 was significantly better than that of control group. In terms of primary endpoint assessment, the clinical recovery rate in common type subjects of treatment group was significantly better than that of control group (71.43% and 55.86% respectively) at the end of treatment. In terms of secondary endpoint assessment, average antifebrile time of treatment group and control group was 2.5 days and 4.2 days, which means the treatment group is better. The time in relieving cough of treatment group was also significantly better than that of control group, with the average time of relieving cough 4.57 days and 5.98 days respectively. In the auxiliary oxygen treatment or noninvasive mechanical ventilation rate of common type subjects during the therapy, the treatment group was significantly lower than control group, respectively with 8.16% and 17.12%. The assessments above all have statistical differences between the two groups.

In terms of accessibility, a domestic enterprise has obtained drug registration certificate from NMPA this February and achieve mass production. Therefore, the supply of clinical drug could be guaranteed.

This article is translated from The Beijing News.

1.Relevant definitions of RWS

RWS refers to the pre-set clinical problems, which is the study process of collecting and studying the data (Real-World Data, RWD) related to research subject’s health or the summarized data derived from these data in the real-world environment, and obtaining the status of drug application and the clinical evidence (RWE) of potential benefits-risks through analysis work (as the figure below shown).

RWD refers to a variety of data collected on a daily basis related to patients’ health conditions and/or diagnosis, treat and healthcare. Not all the RWD could be RWE after analysis, only the RWD meet applicability may produce RWE.

RWE refers to the clinical evidence on the status of drug application and potential benefits-risks obtained through the appropriate and sufficient analysis of the applicable RWD, including the evidence obtained through intervention studies, such as Retrospective Observational Study or Prospective Observational Study or Pragmatic Clinical Trial (PCT) etc.

2. RWE supports drug regulatory decisions

RWE is applied to support drug regulatory decisions, it covers many steps of drug research including pre-market clinical development and post-market re-evaluation.

(1) Provide evidence of efficacy and safety for new drug registration and marketing

According to the characteristics of different diseases, access to therapeutic methods, target population, therapeutic effect and other factors related to clinical research, the efficacy and safety information of drugs can be obtained through RWS, which provides supportive evidence for new drug registration and marketing.

The common real-world studies provide the evidence of efficacy and safety for new drug registration and marketing are: the randomized controlled trials (RCT) with outcome or safety data obtained from RWD, including PCT design, etc; and the single-arm trials based on the RWE as external control, for some rare diseases and serious diseases threaten life lack of effective therapeutic treatments.

(2) Provide evidence for changes of the introduction of marketed drugs

For marketed drugs, new indications generally require RCT support. However, when the RCT is not feasible or the research design is not optimal, it may be more feasible and reasonable to use the RWE generated by PCT of observational study to support the new indications.

In the area of pediatric drugs, using RWE to support the expansion of indication population may be also one of the applicable situations for drug regulatory decision.

In general, RWE supports the changes of instructions of marketed drugs mainly include:

• Add or modify indications;
• Change dosage & administration regimen or routes of administration;
• Add new applicable population;
• Add the results of comparative effectiveness research;
• Add information on safety;
• Other modifications of instructions.

(3) Provide evidence for the requests and re-evaluation of marketed drugs

The drugs approved based on RCT evidence, usually have deficiencies like the limit of safety information, the uncertainty of extrapolation of efficacy conclusions, administration regimen may not be optimal and lack of economic benefits due to limited cases, short research time, strict condition of subject enrollment and intervention standardization. It is necessary to use RWD to conduct a more comprehensive evaluation on effectiveness, safety, use and economic benefits of drugs in real medical practice, and make decisions adjustment according to RWE continuously.

(4) RWE’s other applications used for regulatory decision

• Guide clinical study design
• Locate target population precisely

3. Evaluation of RWE

Evaluation of RWE shall comply with two main principles:

Whether RWE can support the clinical problems that need to be answered or not.

Whether the existing RWD can be scientifically designed, rigorously organized and implemented, and reasonably analyzed to obtain the required RWE.

(1) RWE and their supporting clinical problems

 Before determining to use any evidence including RWE, the clinical problems need to be answered shall be defined first. For example, safety considerations for the combination of a marketed drug with other drugs; new indication researches for approved products; and the establishment of robust and reliable history or external controls for single-arm clinical trials of a rare disease, etc.
 Secondly, it is necessary to consider whether the use of RWE can answer the facing clinical questions. Four aspects shall be evaluated based on scientific validity (for example, scientific interpretability, reasonability of hypothesis and type I error control, etc.), regulatory requirements (whether they conflict with other regulatory requirements, and whether there’s any regulatory requirement in the areas of special disease, etc.), ethical issues (whether ethical issues will be caused without using RWE) and operability (for example, whether there are independent statisticians and ensure that the statisticians are blind to outcome variables to avoid possible bias when matching; whether there’s any other operational challenge, etc.).
 The comprehensive consideration of the above issues is an important criterion to measure the application of RWE.

(2) How to get to RWE from RWD

Basically it’s necessary to consider: ① The research environment and data collection are close to the real-world, such as more representative target population, the diversification of intervention accord with clinical practice, and natural choices of intervention, etc. ② Suitable control. ③ More comprehensive evaluation of results. ④ Effective bias control, such as the use of randomization, the unification of measurement and evaluation method, etc. ⑤ Appropriate statistical analysis, such as correct use of casual inference methods, reasonable processing of missing data and sufficient sensitivity analysis, etc. ⑥ The transparency and reproducibility of evidence. ⑦ Reasonable explanation of results. ⑧ All the parties concerned reach a consensus.

It’s important to note that all research designs, hypothesis and specific definitions related to the generation of RWE shall be stated clearly in the research protocol beforehand. The afterwards supplementary data reference, definitions, analyses and explanations normally cannot be used for regulatory decisions.

4. Communicate with review agencies

It’s necessary to communicate adequately with drug review department when using RWE for the purpose of drug registration, to ensure the two parties has reach a consensus on using RWE and conducting RWS.

When the applicant plans to use RWE to support drug registration matters, it shall apply for communication actively in accordance with the communication channels of drug review department before implementing researches. And perform written or conference communication and discussion from the feasibility of using RWE, research design, data collection and analytical methods.

After completing RWS, the applicant also shall apply for communicating with review department before planning to submit application materials, to communicate and confirm the contents of the research implementation status, research result and conclusion, the requirements of application materials.

This article is translated from the published post of NMPA.

Pharmaceuticals are a matter concerning people’s life and health, and there continues to be a need for finding new treatments and cures, such as for cancer, diabetes, hypertension, and stroke, among others. To promote innovation and cooperation in the pharmaceutical sector and to better meet the needs of patients, the Parties shall provide for effective protection and enforcement of pharmaceutical related intellectual property rights, including patents and undisclosed test or other data submitted as a condition of marketing approval.

Article 1.10: Consideration of Supplemental Data

• China shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and inventive step, during patent examination proceedings, patent review proceedings, and judicial proceedings.
• The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.

Article 1.11: Effective Mechanism for Early Resolution of Patent Disputes

• If China permits, as a condition of approving the marketing of a pharmaceutical product, including a biologic, persons, other than the person originally submitting the safety and efficacy information, to rely on evidence or information concerning the safety and efficacy of a product that was previously approved, such as evidence of prior marketing approval by China or in another territory, China shall provide: (a) A system to provide notice to a patent holder, licensee, or holder of marketing approval, that such other person is seeking to market that product during the term of an applicable patent claiming the approved product or its approved method of use; (b) Adequate time and opportunity for such a patent holder to seek, prior to the marketing of an allegedly infringing product, available remedies in subparagraph (c); (c) Procedures for judicial or administrative proceedings and expeditious remedies, such as preliminary injunctions or equivalent effective provisional measures, for the timely resolution of disputes concerning the validity or infringement of an applicable patent claiming an approved pharmaceutical product or its approved method of use.
• China shall establish a nationwide system for pharmaceutical products consistent with paragraph 1, including by providing a cause of action to allow the patent holder, licensee, or holder of marketing approval to seek, prior to the marketing approval of an allegedly infringing product, civil judicial proceedings and expeditious remedies for the resolution of disputes concerning the validity or infringement of an applicable patent. China may also provide for administrative proceedings for the resolution of such disputes.
• The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.

Section D: Patents

Article 1.12: Effective Patent Term Extension

• The Parties shall provide patent term extensions to compensate for unreasonable delays that occur in granting the patent or during pharmaceutical product marketing approvals.
• China shall provide that: (a) China, at the request of the patent owner, shall extend the term of a patent to compensate for unreasonable delays, not attributable to the applicant, that occur in granting the patent. For purposes of this provision, an unreasonable delay shall at least include a delay in the issuance of the patent of more than four years from the date of filing of the application in China, or three years after a request for examination of the application, whichever is later. (b) With respect to patents covering a new pharmaceutical product that is approved for marketing in China and methods of making or using a new pharmaceutical product that is approved for marketing in China, China, at the request of the patent owner, shall make available an adjustment of the patent term or the term of the patent rights of a patent covering a new product, its approved method of use, or a method of making the product to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process related to the first commercial use of that product in China. Any such adjustment shall confer all of the exclusive rights, subject to the same limitations and exceptions, of the patent claims of the product, its method of use, or its method of manufacture in the originally issued patent as applicable to the approved product and the approved method of use of the product. China may limit such adjustments to no more than five years and may limit the resulting effective patent term to no more than 14 years from the date of marketing approval in China.
• The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.

Section G: Manufacture and Export of Pirated and Counterfeit Goods

Pirated and counterfeit goods severely undermine the interests of the general public and harm right holders in both China and the United States. The Parties shall take sustained and effective action to stop the manufacture and to block the distribution of pirated and counterfeit products, including those with a significant impact on public health or personal safety.

Article 1.18: Counterfeit Medicines

• The Parties shall take effective and expeditious enforcement action against counterfeit pharmaceutical and related products containing active pharmaceutical ingredients, bulk chemicals, or biological substances.
• Measures China shall take include: (a) Taking effective and expeditious enforcement action against the related products of counterfeit medicines and biologics, including active pharmaceutical ingredients, bulk chemicals, and biological substances; (b) Sharing with the United States the registration information of pharmaceutical raw material sites that have been inspected by Chinese regulatory authorities and that comply with the requirements of Chinese laws and regulations, as well as any necessary information of relevant enforcement inspections; (c) Publishing online annually, beginning within six months after the date of entry into force of this Agreement, the data on enforcement measures, including seizures, revocations of business licenses, fines, and other actions taken by the National Medical Products Administration, Ministry of Industry and Information Technology, or any successor entity.
• The United States affirms that existing U.S. measures afford effective and expeditious action against counterfeit pharmaceutical and related products.

This article is from the official website of Ministry of Finance of the People’s Republic of China.

On December 1^st, 2019, the new edition of “China Drug Administration Law” was implemented officially. This is the second major revision of the law since it was promulgated in 1984. The new law has made corresponding adjustment to the import and export regulations, which promotes the continuous improvement of China’s drug import and export supervision legal system.

1.Qualification of the main body engaged in drug import and export activities

(1) Enterprises

i. Qualification of general import and export trade subjects

For drug import and export enterprises, they must obtain the general enterprise qualification to engage in import and export trade:

• According to the provisions of the “Foreign Trade Law”, foreign trade operators who engage in the import and export of goods or technology should file with the foreign trade department of the State Council or its authorized agencies.
• In accordance with the provisions of the “Customs Law of the People’s Republic of China (revised in 2017)”, the consignee or consignor of import and export goods must register with the Customs according to the law when going through the Customs declaration formalities.

ii. Special qualification for importing and exporting drugs

The enterprises of drug import and export must be independent legal person holding the “Drug Service License” and “Drug Manufacture (Service) Enterprise Certificate”. A pharmaceutical manufacture shall also hold the “Drug Manufacture License” when importing APIs and pharmaceutical intermediates (including domestic sub-packaging preparations) of their own. Moreover, enterprises must also obtain corresponding licenses for importing and exporting drugs and perform the specific import and export process.

(2) Medical Institutions

Medical institutions shall not engage in drug import and export business in their daily operations. When there is an urgent need to import a small amount of drugs for clinical purpose, they must get approval from the drug regulatory department of the State Council or the people’s government of a province, autonomous region, and municipality directly under the Central Government authorized by the State Council. Imported drugs shall be used for particular medical purposes in designated medical institutions.

(3) Individuals carry or post drugs

Individuals who enter or leave China with a small amount of drugs for self-use shall follow the relevant regulatory provisions of the Customs.

• For the entry and exit of overseas drugs for self-use, the Customs department shall supervise them according to the principles of ‘reasonable, self-use and small amount’, and Customs clearance shall be conducted in accordance with personal articles without submitting the relevant import licenses, and duty-free release.

• For non-prohibited articles, in general the Customs will inspect and release them directly. However, if the value of the drugs carried exceeds the ‘self-use’ limit prescribed by the Customs, or its nature cannot be judged as ‘reasonable for self-use’, the Customs will request the post consignee or carrier to provide evidence such as diagnostic instructions, prescriptions, purchase records, overseas marketing license and drug instructions etc., to prove the rationality of self-use. 

(4) Education and research institutions

Order No. 221 of the General Administration of Customs (“Provisions on the Administration of Registration of Customs Declaration Unit of the People’s Republic of China”) stipulates that schools and scientific research institutes and other organizations that have not obtained the file registration form for foreign trade operators and need to engage in non-trade import and export activities, shall go through the temporary registration procedures in accordance with the relevant provisions of China; the temporary registration units shall go through the file formalities with local Customs before declaring to the Customs. After completing the above procedures, the education and research institutions can import and export common drugs according to the normal process. If the import or export drugs involve special regulatory areas, the education and research institutions must obtain the corresponding qualifications.

2. Channels of Import and export drugs

(1) Cargo channel – designated port

Drugs shall be imported from the ports where the drugs are permitted to import, and enterprises importing drugs shall file with the drug regulatory department at the place where the port is located. The Customs shall go through the clearance procedures on the strength of the import drug clearance form issued by drug regulatory department. Without the clearance form for the imported drugs, the Customs shall not release them. The drug regulatory department at the place where the port is located shall notify the drug inspection agency to conduct spot check and inspection on imported drugs in accordance with the provisions of the drug regulatory department of the State Council. Currently 24 port cities are permitted to import drugs: Beijing, Tianjin, Shanghai, Dalian, Qingdao, Chengdu, Wuhan, Chongqing, Xiamen, Nanjing, Hangzhou, Ningbo, Fuzhou, Guangzhou, Shenzhen, Zhuhai, Haikou, Xi’an, Nanning, Suzhou, Jinan, Changsha, Zhengzhou and Shenyang.

(2) Post Channel – Customs postal supervision place

Drugs (non-prohibited drugs) that enter or leave China by post are imported or exported by ordinary goods, and they shall be subject to the postal supervision of the Customs. According to the General Administration of Customs announcement No.43 of 2010 “Matters concerning the adjustment of management measures on inbound and outbound personal postal articles”, when a drug is posted in and out of the country as a personal article, if it is below the limit (Note: the limit is less than 800 RMB per time for Hong Kong, Macao and Taiwan, and less than 1000 RMB per time for other countries and regions), it can be cleared in accordance with personal articles. But if it exceeds the prescribed limit, declaration shall be made to the Customs based on the facts. Without the custom’s permission, the inbound and outbound express deliveries that haven’t completed Customs formalities shall not be moved out of the place under Customs control, nor shall they be loaded, unloaded, disassembled, repacked, replaced with marks, picked up, dispatched or shipped etc.

(3) Individuals carry – passenger port entry

Drugs (non-prohibited drugs) carried as luggage into and out of the country will enter or leave the country through passenger port according to ordinary goods, and will be subject to the Customs supervision. If the drugs exceed the above limit, declaration shall be made to the Customs based on the facts.

This article is translated from a published post by Dhh Law Firm.

• The newly revised “Drug Administration Law” encourages drug development and innovation in five major areas, and gives priority to reviewing and approving these medicines.
• A risk control mechanism for halting clinical trials at any time has been established.
• The Law introduces an extended clinical trial clause for the drugs used for seriously life-threatening disease.
• The law also broadens the channels for import of unapproved drugs due to clinical urgent needs.
• The model of supervision and administration is changed from “GMP”, “GSP” to “dynamic inspection”.
• If the MAH is a foreign enterprise, the enterprise legal person in China shall be appointed to perform the holder’s obligations and bear joint liabilities.
• The drug regulatory department shall establish drug safety credit files.

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There are 943 words below. If you read it carefully, it will take around 7 minutes.

On August 26^th, 2019, the 12th session of the Standing Committee of the 13th National People’s Congress was held in Beijing, and the meeting voted to approve the amendment to “Drug Administration Law of the People’s Republic of China”. The newly revised “Drug Administration Law” will take effect on December 1^st, 2019. This is the second major systematic and structural amendment to “Drug Administration Law” since its promulgation in 1984, which promotes the reform achievements and effective practices in the pharmaceutical field into law, and also provides stronger legal guarantee for public health.

This revision incorporates drug management concepts into drug quality, medication safety, and public health. It also explicitly encourages drug innovation in therapeutic areas where treatment needs have not been satisfied. There are clear provisions for taking a number of measures to streamline administration, delegate more power, and strengthen the main responsibility.

• Encourage innovation, strengthen risk prevention and control

This revision of the “Drug Administration Law” not only writes many new systems that guide the direction of drug development and innovation into the law, but also has a breakthrough optimization of the review and approval process. It also established a matching “brake” mechanism to speed up registration review and strengthen drug risk prevention and control.

1. Emphasis on encouraging innovation is guided by “clinical value”. The innovation is defined from multiple angles of clear or special curative effects, new treatment mechanisms, and systematic adjustment of intervention functions. It reflects the encouragement of breakthroughs in clinical translational innovation from the source of basic medicine. This is a policy shift from encouraging imitative innovation to encouraging source innovation
2. Drug development and innovation in five major areas are explicitly encouraged: medicines for severely life-threatening diseases, medicines for treating rare diseases, medicines for children, urgently needed medicines in clinical shortage, and medicines for preventing and treating major infectious diseases. These five categories of drugs all fall in the field of disease treatment that has not yet met clinical needs, and are also in areas of high investment in research and development and high risks. China encourages the development and production of medicines in short supply, and gives priority to reviewing and approving medicines that are urgently needed and new medicines that prevent and treat major infectious and rare diseases.
3. In the “Drug Administration Law”, to consolidate the exploration of drug review and approval system, the implied clinical trial licensing system, bioequivalence filing system and clinical trial institution filing system are written into the law. At the same time, a risk control mechanism for halting clinical trials at any time has been established.
4. The “Drug Administration Law” introduces an extended clinical trial clause, which stipulates that for the drugs those are undergoing clinical trials to treat diseases that are seriously life-threatening and have no effective treatment, if they may generate benefit according to medical observation and conform to ethical principles., After review and informed consent, the drugs could be used for other patients with the same condition in the institution where the clinical trials are conducted.
5. Another important item we need to pay attention is: the law broadens the channels for import of unapproved drugs due to clinical urgent needs. Medical institutions could import a small amount of drugs due to clinical urgent needs after the approval by the drug administrative department of the State Council of China, or approved by the people’s governments of provinces, autonomous regions and municipalities directly under the central government authorized by the state council. At the same time, in accordance with relevant national regulations, individuals are allowed to bring a small amount of drugs from abroad for their own use.

• Streamline administration, delegate power, and strengthen the main responsibility

1. The “Drug Administration Law” also canceled the certification clause of “Good Manufacturing Practices (GMP)” and “Good Supply Practices (GSP)”. The law requires companies to continue manufacturing and supplying in accordance with regulations. The model of supervision and administration is changed from “periodic certification” to “dynamic inspection”.
2. The newly revised “Drug Administration Law” specifically includes Chapter III “Drug Marketing Authorization Holders (MAH)”. The holder of a drug marketing authorization is responsible for the safety, effectiveness, and quality of the drug during the entire process of drug development, manufacture, supply, and use.
   • The qualifications of holders are relaxed. The MAH refers to the enterprise or a drug development institution that has obtained a drug registration certificate. The binding relationship of the drug registration certificate and the drug manufacturing license is cancelled.
   • If the MAH is a foreign enterprise, the enterprise legal person in China shall be appointed to perform the holder’s obligations and bear joint liabilities.
   • It is clear that with the approval of the drug regulatory department under the State Council, the MAH can transfer the license to another enterprise. The ownership of the property right of the drug marketing license is confirmed by law.
   • Confirmation of the legal status of MAH as a producer. It is explicitly required that the drug MAH and its address are added to the information that should be indicated on the drug’s label or instruction, contrastively only the information of manufacturer and its address were specified formerly.
   • Clarify the legal responsibilities of drug MAH and other partners, and establish the first responsibility system.
3. The drug regulatory department shall establish drug safety credit files for drug MAHs, drug manufacturers, drug distributors, non-clinical safety evaluation research institutions, drug clinical trial institutions, and medical institutions.

As a conclusion, the newly revised “Drug Administration Law” reflects the China’s pharmaceutical administration system is fully in line with the trend of international standards, and it also reveals the determination of Chinese government to strengthen the protection of drug safety, medication safety and promotion of public health.

AstraZeneca today announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) has received marketing authorisation for roxadustat in China for the treatment of anaemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients.

The approval, granted by the National Medical Products Administration, is primarily supported by a Phase III trial in NDD-CKD patients with anaemia, in which roxadustat demonstrated a statistically-significant improvement in haemoglobin levels from baseline averaged over weeks seven to nine of treatment, with a mean change of 1.9 g/dL compared to -0.4 g/dL with placebo. This data was published in The New England Journal of Medicine in July 2019.

This marketing authorisation follows the approval of roxadustat in China in December 2018 for anaemia in CKD patients who are on dialysis. AstraZeneca and FibroGen China expect to launch roxadustat in China during the second half of 2019.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “With this approval for roxadustat in China, we are now able to provide this first-in-class medicine to all patients living with chronic kidney disease who experience anaemia, regardless of whether they require dialysis. This is a significant milestone and we look forward to bringing the medicine to patients later this year.”

Anaemia caused by CKD is associated with cardiovascular disease, hospitalisation, cognitive impairment and reduced quality of life, and has been shown consistently to increase the risk of death in patients with CKD. Anaemia becomes increasingly common in patients with CKD as their disease progresses.

For more information: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/roxadustat-approved-in-china-for-the-treatment-of-anaemia-in-non-dialysis-dependent-patients-with-chronic-kidney-disease-22082019.html

www.nmpa.gov.cn

Key Takeaways:

• On April 22, Customs announced the cancellation of label filling for imported pre-packaged foods, meaning from 1st Oct 2019, importers and customs brokers will no longer have to submit to China customs product labelling documentation (inclu. Chinese labels) for imported prepackaged food products during importation.
• Speedier market access: improvement of efficiency during customs clearance which enables less administrative paper work and speeds up market access. 
• The importer shall be responsible for reviewing whether the Chinese label of the imported prepackaged food meets the requirements of relevant GB standards.
• Subject to random on-site inspection by customs or for laboratory testing which will require to provide compliant labelling documents including Chinese labels and other supporting materials.
• If the Customs receives complaint regarding violation of Food Safety, Labelling and other relevant GB regulations, Customs shall verify and once confirmed, act according to law such as requesting for recalls, penalties etc.
• Port to Port differences: After communicating with GACC, for some ports, Customs may still require importers to provide labelling documents as part of the check list for Customs Clearance, although they may not examine the labelling documents.

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What next? Risks and Suggestions

Customs have been piloting this scheme for the past few years in some ports including Shanghai and others for lower risk food categories. What’s changed? This change officially applies to all ports and pre-packaged food categories in China.

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• Risk of random customs inspection it is strongly advised to prepare compliance documentation beforehand such as original label and translation, Chinese labels and other relevant supplementing information.
• Responsibility weighed on the exporter and importer to ensure compliance from the very beginning. Discovering product or labelling in-compliance at a later stage when product is already on China market will have a significant impact with the risks of potential recall and penalties. 
• Laissez-faire & Reliance on Consumer Complaints. A shift from government control to let the workings of the free market do the work. Since the announcement of The Food Safety Law, the policy has increased the penalty for non-compliant food items including violations of Chinese labelling rules, this led to the rise of industry of professional complainers that can earn compensation of 10 times the purchase price. This has encouraged the market to identify non-compliant products to report to Chinese authorities.

Reference (Chinese Only): http://www.customs.gov.cn/customs/302249/302266/302269/2393416/index.html

Contact: Raymond@Accestra.com

Website: www.accestra.com