Release MAH system dividend Domestic risk-based drugs after the market change guide is to be issued.

Author . . . On Friday, July 31, 2020, the official website of the State Drug Administration issued a notice for public consultation on the Measures for the Administration of Changes after Drug Marketing (Trial) (Draft for Comments), and the deadline for comments is August 15, 2020, which is the first guidance document specifically drafted specifically for post-marketing change management of drugs in China, which will provide more systematic and operational requirements for china's post-marketing supervision and regulation of drug listing license holders (hereinafter referred to as MAH).
We see is not only how to carry out the specific requirements of post-marketing change management of drugs, behind the reflection of the complexity of drug post-marketing changes and the new regulatory era of scientific regulatory considerations, fully reflects the strengthening of after-the-fact supervision and management concept, fully release the MAH system dividends.
this paper analyzes the pain points of drug post-marketing change management and the highlights of "Measures for the Management of Change after Drug Listing (Trial)" (draft for comments).
I. Change management pain point drugs after the drug market, related to people's lives and health, related to public health safety and national security, but in recent years after the drug market changes, especially the production process changes appear in some cases, let us pay more attention to the management of drugs, 2018 long-life biological vaccine fraud case (arbitrary change of process parameters and equipment)," will be different batches of raw fluids to tick the preparation, and then the original liquid after the batch re-production batch, production batch The use of centrifnd changes not recorded in accordance with the provisions), exposing the existence of some enterprises change research level and risk control level is uneven, the change control and management of insufficient attention, the implementation of related research is not sufficient, for the above reasons, the State Drug Administration, one by one, plug loopholes, in order to encourage holders to continuously improve the process, improve and ensure the quality of drugs, the implementation of the new revision of the Drug Management Law on December 1, 2019 separately proposed the drug market change management chapter, This is an important part of establishing a quality control system for the whole life cycle of pharmaceuticals.
2, "Drug post-marketing change management measures (trial)" highlights first look 2.1 scope of application 2.2 to the standard international standard change classification and dynamic management of more scientific changes are based on scientific research and scientific awareness, with the production management level and production technology continue to improve, different periods of the same change category will be determined different, its risk level may also be different.
"Measures for the Administration of Changes after Drug Listing (Trial)" based on the development status quo of changes after the listing of domestic drugs, drawing on the advanced management concepts of developed countries, combined with relevant regulations and technical requirements at home and abroad, in line with the principles of scientific, operability, forward-looking and advanced, the risk assessment rating of each change is based on science and risk, in accordance with the implementation of the "Drug Registration Management Measures" on July 1, 2020 into three categories. In the course of
classification, reference is made to the relevant guidelines issued by WHO, FDA, EMA, etc., so in principle, the risk classification of each change is consistent with the international consensus, in the change classification principle, the change management category is divided into major changes, medium changes and minor changes, respectively, in accordance with the relevant provisions approved, filed after implementation or reporting, the holder is responsible for the authenticity, accuracy and completeness of the information submitted.
, changes in production supervision shall be carried out in accordance with the relevant provisions of the Measures for the Supervision and Administration of Pharmaceutical Production.
and make it clear that MAH may make adjustments to the change management category based on changes in management and production technology, and implement or report on the newly determined change management category after approval, filing, MAH is unable to determine the change management category or the change management situation to be set out in the guidelines If the adjustment of the management category can be carried out in accordance with the provisions after communication and agreement with the drug regulatory department on the basis of full research and verification, and no agreement can be reached, the provincial drug regulatory department shall refer the state bureau's drug review center to assist in clarifying the management category, and the drug review center shall reply within 30 days.
changes to drugs produced abroad cannot confirm the type of change management, the drug review center may communicate with the drug review center on the basis of full research and verification, in accordance with the relevant procedures for drug registration communication and exchange.
2.3 Release of the signal of the cancellation of the technology transfer approval system "Measures for the Administration of Changes after Drug Listing (Trial)" The last provision of the Draft for Comments, i.e., "Date of Implementation": These Provisions shall be effective from the date of publication, the former State Food and Drug Administration issued the "Notice on the Issuance of The Regulations on the Registration of drug Technology Transfers" (No. "Notice on the implementation of the newly revised drug production quality management norms related to drug technology transfer" (National Food and Drug Administration Note (2013) No. 38) repeal, worthy of MAH special attention, release the cancellation of technology transfer approval system signal, change to MAH change, effectively release the MAH system dividend, which will bring about a landmark change in China's pharmaceutical technology market.
This third, looking forward to the current release of the new version of the Drug Administration Law (revised in 2019 Presidential Decree No. 31) and the 2010 version of the drug GMP has been implemented and has not yet landed on the "drug after the change management measures (trial)" for comments can be clearly reflected The Domestic Drug Administration is aware of the importance and necessity of risk control of change control of production process after drug listing, and is actively improving and reconstructing the whole legal and regulatory system, establishing a perfect system action to control post-market changes of drugs, and hopes that the Measures for the Management of Changes after drug listing (trial) will be issued and implemented as soon as possible.
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