In terms of approval, in 2019, the acceptance number has obtained review comment is 1,855. Among them, there are 834 approval clinical acceptance numbers, 427 approval manufacturing acceptance numbers and 99 imported acceptance numbers have been approved. Compared with the approved number in 2017 and 2018, the overall is in a fluctuation condition, which has a direct connection with the changes in registration approval policies and the increase of domestic review in recent years.

According to the statistics, it takes 427 days (50% shorter than 2018) for NDA and 1,205 days for ANDA (13% shorter than 2018). Among them, for imported new drug applications, the products has got priority review can be reviewed in 363 days, non-priority review products need 570 days to complete their reviews. However, it takes 422 days to complete the review of a domestic new drug has been given priority review.

1.Chemical drugs application statistic information in 2019

In 2019, 6,106 application acceptance numbers of chemical drugs involve 1,263 active ingredients and 1,470 enterprises. In the 6,106 numbers, the number of domestic chemical drugs is 3,256, accounting for 53%, and the imported chemical drugs application acceptance number is 2,850 which accounts for 47% (as the image below shown).

Note: Others in application content include: re-registration application, re-review, supplementary application and other applications. Other types include: supplementary application, re-review and other applications.

From the perspective of application type in recent 3 years, the NDA acceptance number has gradually increased and grown steadily, which has a close relation with China’s encouraging innovation policy. And the imported application acceptance number decreased slightly in 2018 has begun to increase substantially in 2019.

Note: Data based on Insight application progress database statistics to Dec. 31th 2019.

From the point of view of registration type, in 2019, there are 516 acceptance numbers of type 1 new drugs involving 221 products. In which, domestic type 1 NDA acceptance numbers are 332 involving 143 products, and 184 acceptance numbers of imported type 1 new drugs involving 78 products. For the improved type 2 new drugs, the number is 176 which involves 8 products. The number of type 3 and type 4 generic drugs are 221 (123 products) and 699 (201 products) respectively. And there are 271 acceptance numbers of type 5.1 and 129 acceptance numbers of type 5.2.

2. Chemical drugs approved statistic information in 2019

Among the 1,855 chemical drug acceptance numbers approved for CDE review and approval in 2019, domestic products acceptance numbers are 1,289, and import products acceptance numbers are 566. In terms of clinical approval, the number of clinical approvals started to increase in 2019 due to the negative comment clinical system, has reached a total of 827. In terms of marketing approval, 427 numbers are approved and 99 imported numbers are approved in 2019.

As of January 3 2020, the largest number approved of 2019 is supplementary application, followed by imported drug approval.

Note: The statistic time is Jan.3st 2020, statistics at different time points will cause differences in the number review comments. (This data is from Yaozhi)

This article is referenced and translated from Insight database and Yaozhi. We’ll get further detailed information at mid 2020 when CDE release official annual report of 2019.

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