After the State Council issued the Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation of Drugs and Medical Devices (“Opinions”) on 8 October 2017, China Food and Drug Administration (“CFDA”) issued the revised draft of the Administrative Measures for Drug Registration (“Draft”) for comments on 23 October 2017. The draft is open for public comments until 25 November 2017.
Compared to the current effective version, the Draft changes a number of articles and introduced several new regimes. These changes are mainly in the following areas:
1. The regime of Market Authorisation Holders (“MAH”) will be fully implemented
China is going to fully implement the MAH system. MAHs are responsible for supervising the safety, effectiveness and quality of their drugs. This liability exists throughout the whole life cycle of the drugs. Under the MAH regime, a domestic applicant shall be a drug manufacturer or a drug research institution which is legally registered in China as an independent legal person; a foreign applicant shall be a legally established pharmaceutical company outside the territory of China which should entrust a domestic legal person as their agent to proceed with the registration. The domestic agent shall have the capacity to ensure the quality of the drug, to prevent and control risks and to compensate for any damage caused.
2. The classification system of drugs will be changed
The Draft further clarifies the classification system of drugs under the registration regime:
- Chemical drugs are further classified as innovative drugs, improved drugs and/or generic drugs;
- Bio-products are further classified as new bio-products, improved bio-products and/or biosimilar products;
- Traditional Chinese Medicines and natural drugs are further classified as innovative drugs, improved drugs, similar drugs with same prescription (同方类似药) and/or ancient classical prescription drugs.
3. The approval regime of clinical trials will be simplified
Applicants should get their clinical study proposal approved by the ethics committee before submitting the application to CFDA. If they do not receive any negative opinions or additional queries within the prescribed time limit from the authority, their applications will be deemed to be approved.
4. Patent Linkage will be established
When applying for marketing approval, applicants should clarify whether their applications involve any patent that the Chinese government granted and if so, the status of that patent, and whether there is any infringement of the patent. They also have the obligation to inform the relevant patent holders that a drug relevant to his/her patents has been submitted for approval.
The relevant regulations on patent linkage shall be drafted separately.
5. Overseas trial data will be accepted
If the drug is to be marketed in China for the first time, when the applicant files the application with overseas clinical data, specific clinical trial data should be provided to identify if there is racial diversity.
The specific regulation on accepting overseas data shall be drafted separately.
6. Data protection regime will be changed
Qualified applicants can submit an application for data protection together with their application for marketing approval. If the drug is an innovative drug, a drug used for rare diseases, a paediatric drug, a biological product used for breakthrough therapies, or if the applicant has challenged a relevant patent successfully, then the applicant could apply to protect their undisclosed trial data or other data as long as they obtained the data on their own. The authority will not approve other similar drugs from other applicants unless the applicant agrees or if the other applicants obtained the data independently.
The specific regulation on data protection shall be drafted separately.
7. The examination process will be quicker
The examination term for clinical trial applications of new drugs is shortened by 30 days, from 90 days to 60 days from the date of acceptance. The examination term for marketing approval for new drugs is also shortened by 30 days, from 150 days to 120 days from the date of acceptance.
8. Liabilities for non-compliance will be clarified If an applicant is found to have provided fraudulent drug registration information and sample products during the drug registration, CFDA shall not accept or approve such application. No registration application for such drug from the same applicant will be accepted for three years from the day of discovery. No application for any drugs from the same applicant will be accepted for one year from the day of discovery. If the registration application has already been accepted, it will not be approved.
CFDA will also review the previous market approvals issued to such applicant. If fraudulent information was found, such previous approvals will be cancelled and no application for any drug from the same applicant will be accepted for the next five years. A record of fraudulent conduct by the applicant shall be maintained and published.
The Draft generally follows the content of the Opinions and aims to shorten and simplify the lengthy drug registration regime in China. Although some specific regimes are mentioned only generally in the Draft, such as the data protection and patent linkage regime, it is expected that specific rules will be drafted and issued soon. We will monitor developments and provide updates in due course.