The National Medical Products Administration (NMPA) has cancelled another 16 certification items, including those related to pharmaceuticals and medical devices.

       This newspaper reports (Reporter Zhao Peng) From drug production licenses to drugGMP certificates, in the future, relevant enterprises will be able to submit fewer proofs when handling related matters. Yesterday, a reporter learned that the National Medical Products Administration (NMPA) issued the "Announcement on Canceling 16 Proof Items," deciding to cancel some proof items for the second time this year after canceling 36 proof items for the first time in April.

       The reporter noted that the 16 proof items canceled this time by the NMPAcover drugs, pharmaceutical products, medical devices, special cosmetics, etc. Among them, 3 cosmetic proof items have been changed to online verification, 9 drug proof items have been changed to internal verification, and 4 medical device applications no longer require applicants to submit organizational chart codes.

       Specifically, these include the drug approval documents required for the application for protection of traditional Chinese medicine varieties, drug production licenses, drugGMP certificates, re-registration acceptance notification required for temporary drug import applications, and relevant documents required for temporary import applications for Hong Kong, Macao, and Taiwan pharmaceutical products. After these proof items are canceled, the drug regulatory authorities will no longer require applicants to submit them, but instead conduct internal verification.

       The NMPA stated that in order to reduce burdens and improve services, more and more proofs are being canceled, and the application and approval procedures for drug-related enterprises will become simpler and faster.

       In fact, this year's speed-up measures for NMPA approval are far more than that. Since this year, the NMPA's drug evaluation center hasincluded more than 70 drugs in priority review, among which several major domestic and foreign products used to treat malignant tumors are expected to be accelerated to market, which will undoubtedly better meet the needs of domestic patients for drugs.

       It is worth noting that among these drugs included in priority review, there are many“star drugs” that patients urgently need. For example, Roche's trastuzumab injection is a targeted anti-cancer drug used to treat breast cancer; AbbVie's adalimumab injection is used to treat rheumatoid diseases.

       The reporter found that, in terms of drug types,38 of the 70 drugs are new drug applications for listing, and another 32 generic drugs are also applying for listing. China’s priority review and approval system will undoubtedly benefit leading pharmaceutical companies in areas such as innovative pharmaceutical companies with strong R&D capabilities, high-quality generic drug companies, pharmaceutical companies exporting preparations, and clinically urgently needed varieties.

       Not only that, this year the NMPA also issued“Announcement on Further Improving the Relevant Matters of the Associated Review, Approval, and Supervision of Drugs”, and some pharmaceutical excipients have received exemption from registration. With the issuance of this announcement, pharmaceutical excipients that have been used for a long time in food and drugs and whose safety has been recognized will no longer need to be registered, and drug preparation applicants can simply list the product list and basic information in the preparation application materials.

       The reporter also learned that the simultaneously released2019 version of the catalog of products that can be exempted from registration shows that some flavoring agents, fragrances, pigments, and pH adjusters used in drug preparations can be exempted from registration. The NMPA also disclosed that administrative licenses for pharmaceutical excipients and pharmaceutical packaging materials have been canceled, and platform registration no longer charges fees.