China Life Sciences & Healthcare Monthly Update – September 2018

Vaccine scandal in China, 16 August

The communist party’s most powerful body, Politburo Standing Committee of the Communist Party of China, decided to sack 6 top officers after the vaccine scandal, including the former head of China National Drug Administration (“CNDA”), Mr. Jingquan Bi.

In July 2018, Chinese vaccine maker Changsheng Biotechnology Corporation (“Changsheng”) was found to have falsified data during the production of 110,000 rabies vaccines. In addition, the same company has been found to have violated standards in producing around 499,800 doses of the “DTP vaccine”, which protects against diphtheria, tetanus and pertussis (whooping cough). Changsheng was fined CNY3.44m (GBP393,845) and could be delisted over the scandal. The police arrested Changsheng’s chairwoman and four other senior executives.

According to the Chinese government, there is no report that anyone has been harmed by the substandard vaccines. However, the scandal hit people’s confidence in domestic vaccines.

To read the full text of the government’s newsletter, please click here (in Chinese only).

CDE solicitation on the list of urgently needed drugs, 8 August

The Centre for Drug Evaluation (“CDE”) of the CNDA released the List of Overseas Drugs in Urgent Need (“List”) on 8 August 2018. The List was open for public opinions before 18 August 2018.

The List covers 48 kinds of drugs (names mentioned below) which have been approved to market in the United States, EU or Japan and regarded as urgently-needed drugs by CDE. CNDA will give priority review to the marketing application of these drugs. The applicant can directly file the marketing application without conducting clinical trials in China.

Following the market application, further documentation would be required for the priority examination, including but not limited to:

• marketing certificates of the relevant drug issued by the drug authorities in US, EU or Japan;
• a report of racial sensitivity analysis;
• a post-marketing research plan and a post-marketing plan on risk control; and
• a statement that the application materials submitted in China are the same with the materials submitted to the overseas authority, including the post-market research materials.

Application materials should be prepared in the format of the Common Technical Document (“CTD”) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH")

To read the full text of the List, please click here.

Solicitation on the management of agents of imported medical devices, 2 August

CNDA released the Measures for the Supervision and Administration of Agents of Imported Medical Devices (Draft for Comment) (“Draft”) on 2 August 2018. This Draft is open for public opinions before 2 September 2018.

According to the Draft, an "agent of imported medical devices" (“Agent”) refers to the foreign medical device Market Authorisation Holder1’s (“MAH”) representative office in China, or the Chinese enterprise which is solely entrusted by the foreign MAH.

The Draft lists a number of obligations for the Agent, including the registration of the medical device, adverse reaction reporting, product recalling, product tracking and tracing, updating foreign MAH of Chinese regulation and technical request, assisting the foreign MAN to get approvals and resolving consumer complaints. In addition, the Agent should take joint product liability with the foreign MAH. Where the foreign MAH intends to change its Agent, it should refile the new Agent to the authorities. Before the completion of the refiling, the previous Agent should continuously perform its liability.

Please click here to read the full text of the Draft (in Chinese only).

CNDA adjusts the proceeding of clinical trial application, 24 July

CNDA released the Announcement on Adjusting Evaluation and Approval Procedures for Clinical Trials for Drugs (“Announcement”) on 24 July 2018.

According to the Announcement, it is advisable for an applicant of a new drug to join a communication meeting with CDE of the CNDA before filing the application of the first-time clinical trial. The purpose of the communication meeting is to make sure that the applicant understands the standards and requirements of the clinical trial application. In the communication meeting, CDE will discuss the key technical questions and the safety of the study subjects of the clinical trial with the applicant. After the communication meeting, CDE might ask the applicant to supplement the materials and data with further documentation, following which the applicant can then file the clinical trial application. CDE will finish the format review within 5 days and then issue a Notice of Acceptance (“Notice”). If the applicant does not receive any negative or challenging opinions from CDE within 60 days of the Notice, it means that the application has been approved and the applicant can start the clinical trial.

In each stage of the clinical trial, the applicant can apply for communication meetings to CDE if the applicant is not sure about any key technical issues.

Please click here to read the full text of the Announcement (in Chinese only).

Rules of accepting overseas clinical trial data, 10 July

CNDA issued the Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs (“Principles”) on 10 July 2018, which standardise the rules of accepting the overseas clinical trial data of drugs.

This effective version generally follows the previous draft. According to the Principles, overseas clinical trial data provided by applicants for drug registration in China shall be complete, correct, true and traceable. The process of obtaining the overseas clinical trial data shall comply with both the Good Clinical Practice of China and that of ICH. The applicant shall submit comprehensive data concerning biopharmaceutics, clinical pharmacology, effectiveness and safety. After a review, the CNDA may choose to fully accept, partially accept or refuse to accept the submitted overseas data. The rule may be relaxed for drugs that are partially accepted when it relates to applications for drugs of critical and rare diseases or paediatric medication and provided that the market currently lacks an effective treatment.

Please click here to read the full text of the Principles (in Chinese only).

1 Market Authorisation Holder: A Marketing Authorisation Holder (MAH) is a company, firm or non-profit organisation that has been granted a marketing authorisation. The marketing authorisation allows the holder to market a specific medicinal product in specific countries.