On 20th of April 2019, the 10th Standing Committee meeting of the Thirteenth National People’s Congress in China (“NPC“) was held in Beijing, the draft amendment to the Drug Administration Law (“Amendment DAL”) was submitted for a second review, and below key amendments are announced and discussed:
- 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.