Release MAH System DividendS The guidelines for changes after the market of risk-based drugs are to be issued.

On Friday, July 31, 2020, the official website of the State Drug Administration issued a public consultation "After-Market Change Management Measures (Trial) " (draft for comments), the deadline for consultation August 15, 2020, which is the first domestic guidance document specifically drafted for the post-market change management of drugs, will be China's drug after the market supervision work and regulate the drug market licensing holders (hereinafter referred to as MAH) after the drug market change selling more systematic and operational requirements.
what we see is not only the specific requirements of how to carry out the change management after drug market, reflects the complexity of the change after the drug market and the scientific regulatory considerations of the new regulatory era, fully reflects the management concept of strengthening the after-the-fact supervision and discharge of the service, and fully release the MAH system dividend.
this paper analyzes the highlights of the post-marketing change management pain points and the Measures for the Management of ChangeS after Drug Market listing (Trial) (Draft for Comments).

, drug after the market change management pain point drugs, related to people's life and health, public health security and national security, but in recent years after the drug market changes, especially the production process changes appear some situation, let us pay more attention to the management of drugs, 2018 long-lived biological vaccine fraud case (arbitrary change of process parameters and equipment), the different batches of the original liquid to prepare, and then the original batch of the original batch of the batch after the production of the batch of the production of the original batch of the production of the batch, the use of the original batch of the production of the drug The change of centrifuge scantiates is not filed in accordance with the regulations), which reveals that some enterprises have different levels of change research and risk control, insufficient attention to change control and management, inadequate research, and so on, on the basis of the above reasons, the State Drug Administration has cited three, closing loopholes, in line with the goal of encouraging holders to continuously improve the process, improve and safeguard the quality of drugs, the new revised "Drug Administration Law" implemented on December 1, 2019 separately proposed the drug after the listing management chapter, This is an important part of establishing a quality control system for the whole life cycle of medicines.
II. The "Drug After Market Change Management Measures (Trial)" highlights a first look at the scope of application 2.1
2.2 standard change classification and dynamic management more scientific changes are based on scientific research and scientific awareness, with the continuous improvement of production management level and production technology, the same change situation in different periods of the category of determination will be different, its risk level may also be different.
the Measures for the Administration of Changeafter After Drug Marketing (Trial) based on the development status quo of changeafter-based drug marketinofs in china, drawing on the advanced management concepts of developed countries, combining relevant regulations and technical requirements at home and abroad, drafting in the principle of combining scientific, operability, forward-looking and advanced nature, and classifying the risk assessment of each change matter is based on science and risk, and is divided into three categories according to the Measures for the Administration of Drug Registration implemented on July 1, 2020.
the classification process refers to the relevant guidelines issued by WHO, FDA, EMA, etc., so in principle, the risk classification of changes 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 submission of information.
, changes in production supervision matters shall be carried out in accordance with the relevant provisions of the Measures for the Supervision and Administration of Drug Production.
and clearly, MAH may adjust the change management category after the decision according to management and production technology changes, and in accordance with the newly determined change management category is approved, implemented or reported, MAH can not determine the change management category or to adjust the management category of change management as specified in the guiding principles, may communicate with the drug regulatory department on the basis of full research and verification and reach agreement, after the implementation according to the provisions, the provincial drug regulatory department can not be transferred to the National Bureau of Drug Review Center to assist in the change management category within 30 days. If changes to drugs produced abroad
cannot confirm the change management category, they 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 communication.
2.3 Release of signals of the cancellation of the technology transfer approval system "Measures for the Administration of Changes after Drug Market listing (Trial)" "The last provision of the Draft for Comments" "The implementation date", i.e., the implementation date: These provisions shall come into effect from the date of publication, the original State Food and Drug Administration issued the "Notice on the issuance of the regulations on the registration and management of drug technology transfer" (National Food and Drug Administration Note (2009) No. 518 "Notice on the implementation of the new revised quality management norms for pharmaceutical production related matters related to drug technology transfer" (National Food and Drug Administration Note (2013) No. 38) repeal, worthy of MAH's special attention, the release of the cancellation of technology transfer approval system signal, change to MAH change, effectively released MAH system dividends, which will bring a landmark change to China's pharmaceutical technology market.
, the outlook has been issued a new version of the "Drug Administration Law" (2019 revision No. 31 Chairman's Order) and has been implemented in the 2010 version of the drug GMP and has not yet landed the "drug market change management measures (trial)" draft can be clearly reflected, The Domestic Drug Administration is aware of the importance and necessity of the change control of the production process after the drug market, and is actively improving and reconstructing the whole legal and regulatory system, establishing a sound system action to control the change after the drug market, and hopes that the Measures for the Management of Changes after Drug Listing (Trial) will be released and implemented as soon as possible.
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