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On November 29, the State Food and Drug Administration (NMPA) publicly solicited comments on the Provisions on the Implementation of the Supervision and Administration of Drug Quality Subject Responsibility by Drug Marketing Authorization Holders (Draft for Comments) (the Draft for Comments), with a deadline of December 9
, 2022.
The Draft aims to further strengthen the holder's main responsibility for quality throughout the life cycle, and it emphasizes that the holder should comply with the Drug Administration Law of the People's Republic of China and other relevant laws and regulations, establish and improve the drug quality management system in accordance with the requirements of good manufacturing practice, good management practice for drug trading, and pharmacovigilance quality management practice, and conduct drug development, production, and operation in accordance with the law.
Responsible
for the safety, effectiveness and quality controllability of the whole process of use.
The Draft further clarifies the responsibilities of key personnel and summarizes the responsibilities and qualification requirements of key positions of holders
.
At the same time, the new requirements and new systems of quality management are also summarized and emphasized, emphasizing the effective operation of the holder's quality management system, clarifying the working mechanism that the holder should establish to implement the main responsibility of quality, and forming an effective guarantee
for the quality and safety of drugs.
Among them, Article 13 [Requirements for the Management of Raw and Auxiliary Packaging] puts forward special requirements
for the audit of pharmaceutical packaging material suppliers.
.
, 2022.
The Draft aims to further strengthen the holder's main responsibility for quality throughout the life cycle, and it emphasizes that the holder should comply with the Drug Administration Law of the People's Republic of China and other relevant laws and regulations, establish and improve the drug quality management system in accordance with the requirements of good manufacturing practice, good management practice for drug trading, and pharmacovigilance quality management practice, and conduct drug development, production, and operation in accordance with the law.
Responsible
for the safety, effectiveness and quality controllability of the whole process of use.
The Draft further clarifies the responsibilities of key personnel and summarizes the responsibilities and qualification requirements of key positions of holders
.
At the same time, the new requirements and new systems of quality management are also summarized and emphasized, emphasizing the effective operation of the holder's quality management system, clarifying the working mechanism that the holder should establish to implement the main responsibility of quality, and forming an effective guarantee
for the quality and safety of drugs.
Among them, Article 13 [Requirements for the Management of Raw and Auxiliary Packaging] puts forward special requirements
for the audit of pharmaceutical packaging material suppliers.
Article 13 [Requirements for the Management of Raw and Auxiliary Packaging] The holder shall audit suppliers of raw materials, auxiliary materials, packaging materials and containers that directly contact drugs, and ensure that the raw materials, auxiliary materials, packaging materials and containers that are in direct contact with drugs purchased and used meet the requirements for medicinal use, and comply with the relevant requirements of quality management specifications formulated by the drug regulatory department under the State Council and the corresponding related review and approval, as well as the requirements
of laws and regulations.
Article 14 [Change Management Requirements] puts forward requirements
for the establishment of a post-marketing change control system for drugs.
Article 14 [Change Management Requirements] The holder shall establish a post-marketing change control system for drugs in accordance with the relevant provisions on drug supervision and the requirements of good manufacturing practices, formulate and implement internal change classification principles, change items, work procedures, and risk management requirements, and determine the change management category after full research, evaluation, and necessary verification in combination with product characteristics, and implement it after approval, filing, or indicate it in the annual report
.
Where production is commissioned, relevant research, evaluation and necessary verification
shall be carried out jointly with the entrusted production enterprise.
In addition, Article 23 [Requirements for Drug Safety Incidents] stipulates that in the event of a safety incident related to drug quality, the holder shall immediately take effective measures to dispose of the relevant drugs and their raw materials, excipients, packaging materials and containers and relevant production lines that directly contact drugs, so as to prevent the harm from expanding
.
.
