As mentioned in our previous news given on 13th of April (details of previous news are accessible here), National medical products administration (NMPA) issued a notice (No. 79) on 31^st of October 2018, which is “The review and approval process for urgent clinical needs foreign drug”, illustrating how the fast track procedures work for “urgently needed” drug, which can be divided into 3 conditions as follows: 

1. For drugs that the clinical trial application has not been applied yet, the applicant may apply for MA to CDE directly;
2. For drugs that clinical trial application has previously submitted already but the technical review has not been completed, the applicant may submit a written application to the CDE to adjust the CTA to MA application, and supplement all the research data obtained abroad and relevant supporting materials to prove there is no racial differences.
3. For the drugs that clinical trials are on-going, the applicant can apply to CDE for MA at the same time while continuing clinical trials. Upon completion of the clinical trial, the applicant should submit all research reports to the CDE in a supplementary application form

CDE will establish special technical review process for new drug in the “urgently needed” list: the technical review timeline can be shortened to 3 months for orphan drugs and 6 months for other new drugs, while the standard technical review time for new drug is normally 120-160 working days.

Official link of the annual report: http://www.nmpa.gov.cn/WS04/CL2151/337665.html

1.China’s drug manufacturing and operating license

It can be indicated from the statistical chart below there is steady increase of licensed API and drug product manufacturing company from year 2016 to year 2018, while the number of retail chains and drugstores are increasing significantly. Large pharmacy chain companies are gaining more market share through acquisition and expansion by opening more regional stores.

2. Drug registration application and approval statistic

• There are 312 new drug clinical trial applications approved by China CDE in year 2018;
• There are 58 generic drug clinical trial applications approved by China CDE while there are 464 total applications in year 2018;
• China CDE accepted a total of 154 applications for imported drugs, and total marketing approval number of imported drugs is 90.
• The state administration approved a total of 1862 supplementary drug applications. A total of 3,276 supplementary drug applications were approved and 12,648 were filed by the provincial (district, municipal) bureaus

3. Protection of Traditional Chinese Medicine Varieties

By the end of November 2018, there were 192 certificates of Traditional Chinese Medicine protected varieties, including 99 for the first time, 4 for the same variety and 89 for extended protection period.

4. Complaint reporting

In 2018, a total of 64,000 drug complaints and reports were accepted by regulators at all levels, with 3,556 cases registered and 4,036 cases closed.

5. Investigation/ punishment cases

In 2018, a total of 98,000 drug cases were investigated and punished by regulators at all levels, with 2.74 billion Yuan worth of goods, 7.66 billion Yuan fines, 2.02 billion Yuan illegal gains were confiscated. Also, there are 1,037 unlicensed businesses banned, 148 fake production and sales dens destroyed, 1,093 enterprises were ordered to suspend production and business, 197 licenses revoked and 2,000 licenses transferred to judicial organs.

In 2018, regulators at all levels investigated and dealt with 249 cases of pharmaceutical packaging materials, with total value of 1.264 million yuan worth of goods.

• Strengthen the regulation of internet drug sales: Any third-party online platform for drug-selling to be filed with government, qualification examination is required to be done. Prescription drugs shall not be sold directly through any third party online platform.
• Inflated drug price and drug shortage are two typical problems in China in the past, the further amendments of the DAL mentions that government shall strengthen the drug prices monitoring work, and relevant departments under the state council may take appropriate measures in the drug production, price intervention and organizing drug importation to prevent and mitigate the drug shortage issue.
• Further clarify the responsibilities of Marketing Authorization Holder(MAH) in the entire life cycle. Marketing authorization holder shall be responsible for the whole process from non-clinical research to clinical trials, production to marketing and post-marketing monitoring for any adverse reactions. Moreover, the holder shall sign an agreement with the enterprise entrusted to produce, market, store and transport the drug, ensure the service quality and risk management ability.
• Encourage pharmaceutical clinical value-oriented innovations, accelerate the review and approval of clinical-needed innovative drugs, especially for anticancer drugs, children’s’ drugs, and orphan drugs. Moreover, as the key to drug development, clinical trials should be conducted complying with ethical principles. In the draft amendments, it further clarifies the ethics committee’s responsibilities to fully protect patients’ right to know and right to choose during clinical trials, which mean all risks should be truthfully stated to patients, patients’ consent should be obtained.

It is worth noticing that although the draft revision of the Drug Administration Law has not yet passed and will be further discussed on the next deliberation of the NPC. However, the cancellation of compulsory GMP and GSP certification, the establishment of Marketing Authorization Holder(MAH) system, the implementation of whole-process supervision, and the strengthening of penalties for drug-related violations have become recognized reform directions in and out of the industry, which will lead to fundamental changes in China’s drug regulatory path, as well as huge changes in the way the industry develops.

Although the number of Chinese first rare diseases list is small comparing with the over 7,000 rare diseases recognized globally, consider the large overall population in China, total patient number that suffered from the listed rare disease cannot be underestimated. Researchers estimate there are at least 16.8 million Chinese with rare diseases.

With the continual publication of the rare diseases catalogue by Chinese government, positive gains will be made with increasing funds and efforts in the field of clinical and science research, also it is predicable that more overseas clinical-valued drugs, effective and affordable treatments will be available for patients with rare diseases.

Please click the link at the end to download the whole list .

Off-patent drugs published by China CDE (batch 2)

Last year, Chinese state council executive meeting has proposed to fast track and grant accelerated approval of the urgently needed new drugs in China. In October 31th, 2018, National medical products administration (NMPA) issued an notice (No. 79), published “The review and approval process for urgent clinical needs foreign drug” which jointly work with National Health Commission of the People’s Republic of China. Priority review and a special evaluation channels will be established to fast track review and approve new drugs that are urgently needed. Those on the list and classified as rare disease drugs and other new drugs aims to gain China drug approval within 3 months and 6 months respectively. Please see the list below for your reference.

For more information please contact: info@accestra.com

• All New substances which are not listed in the KECI(Korea Existing Chemical Inventory) must be registered prior the manufacture or import activity.
• All existing chemical substances >=1t/y must be registered within given grace periods.

To benefit from the grace periods for existing substances, manufacturers and importers are obliged to pre-register with Korea authority for all existing chemical substances >=1t/ybefore 30 Jun 2019. For chemicals that are not pre-registered before 30 Jun 2019 cannot enjoy the grace period benefit, thus will not be allowed to export to Korea from 1 July 2019.

The “K-REACH” was enforced back to Jan.1, year 2015. Since then the South Korea’s Ministry of Environment have made several times amendments and the final version is significantly changed from the previous version which officially took effect on 1 Jan 2019. Manufactures and importers shall pay attention to the new requirements of compliance, as well as the following registration deadlines: