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The China Food and Drug Administration (CFDA) published the Invite for Response to the Amendments to the Pharmaceutical Administration Law on 23 October 2017. The amendments propose to confirm and establish a liability system for Holders of Drug Marketing Licenses. In addition, various administrative permits would be repealed, with an aim to streamline the administrative process for pharmaceutical products. The proposed amendments would also increase penalties imposed on violators of the Pharmaceutical Administration Law and introduce the concept of professional inspectors of pharmaceutical products in China.
Specifically, the following revisions are proposed to be introduced to the Pharmaceutical Administration Law:
• A liability system for Holders of Drug Marketing Licenses would be formally established under the Pharmaceutical Administration Law. For instance, it would be spelled out specifically that holders of Drug Marketing Licenses are the ultimate party that bears the responsibilities and legal liabilities for ensuring the safety, effectiveness, and quality of their pharmaceutical products. In addition, holders of Drug Marketing Licenses are liable for activities involving the drugs licensed, such as clinical trials and actual use of a particular drug.
• Various administrative permits would be repealed to streamline the administrative process for pharmaceutical products. For instance, Good Manufacturing Practice Certificate and Good Supply Practice Certificate for Pharmaceutical Products would be repealed.
• Penalties imposed on violators of the Pharmaceutical Administration Law would be increased. For instance, if a pharmaceutical company has its Drug Marketing License revoked due to false information submitted to the authorities, its major responsible persons and other personnel that are directly responsible for this violation would be prohibited from conducting any type of business in the pharmaceutical industry for ten years. Personnel that are subject to criminal liabilities due to violations of the Pharmaceutical Administration Law would be prohibited from conducting any activities related to the research and development, production, sales, import, and export of pharmaceutical products for life.
Public comments on the proposed amendments can be submitted to the CFDA by 30 October 2017 by email here: firstname.lastname@example.org.
Companies that operate in the pharmaceutical industry should expect more stringent requirements for safety assurance of pharmaceutical products if these amendments are approved. For instance, a liability system for Holders of Drug Marketing Licenses would be officially established in China. The proposal would also increase penalties imposed on violators of the Pharmaceutical Administration Law and introduce professional inspectors of pharmaceutical products in China. Affected parties are recommended to review the proposal and submit any comments that they might have to the China Food and Drug Administration by 30 October 2017.