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The GMP Situation in China from 2015

Views:6     Author:golden horizon biologics     Publish Time: 2016-05-17      Origin:Golden Horizon Biologics

To encourage and guide the drug manufacturing enterprises to meet the requirements of the newly revised GMP, the State Food and Drug Administration (SFDA), the National Development and Reform Commission (NDRC), the Ministry of Industry and Information Technology (MIIT) and the Ministry of Health (MOH) has jointly published the “Notice on Accelerating the Implementation of the Newly Revised GMP and Promotion of the Pharmaceutical Industry Upgrade”on 8 Jan 2013.


The new “Good Manufacturing Practices for Pharmaceutical Products (2010 Revision)” (GMP) including the blood products, vaccines, injections, etc. to acquire the new GMP certificate by the end of 2013. The other drug manufacturers shall be licensed before 31 Dec 2015. Those failed to meet the deadline would be abandoned from the Chinese market.


The first deadline for manufacturers producing sterile drugs is approaching. However, factors such as the financial issue, technical support, intrinsic capacity and the wait-and-see attitude have led to a disappointing situation that most of the enterprises have not yet started the reform of new GMP compliance and some have just given up the plan to apply for the new GMP certificate. In this sense, it is challenging to get all the drug manufacturers licensed under the new GMP by the end of 2015, and it is especially difficult to finish the upgrades of manufacturers producing sterile drugs by 2013.


To support compliance with the new GMP requirements, the four governmental agencies have established some measures in the following aspects:


SFDA will accelerate the registration process for manufacturing technology transfer resulting from merger, acquisition and in-group reorganization. For each dosage form of the product, the technology can only be transferred once to a company certified by the new GMP. The application for technology transfer should be submitted before 31 Dec 2014 for sterile drugs and 31 Dec 2016 for other kinds of drugs.


The manufacturers gained the WHO certification or PIC/S certification, or those who with complete quality assurance system and have not been found to have serious defects will enjoy priority in inspection and certification.


The manufacturers failed to meet the respective deadlines would face rejection of their new drug registration applications, and in case of a pending registration application, the approval will be suspended.


In case of contract manufacturing, SFDA will stop granting approval for the commissioned manufacturer to produce sterile drugs if it has not obtained the new GMP certificate before 1 Jul 2013. For the manufacturers commissioned to produce other kinds of drugs, the grace period is extended to 1 Jan 2015.


The drug manufacturers certified by the new GMP will be granted a preferential pricing adjustment.


Those certified with the new GMP will enjoy an absolute advantage in bid procurement. If any of the certified manufacturers participate in bidding, the companies have not gained the new GMP certificate be ruled out from the competition.


China will provide supports to the GMP reform projects of the drug manufacturers.


The GMP is a major measure to assure the safety, efficacy and quality of medical products. The pressure from survivals and the painful lessons learned from medicine scandals have pushed the Chinese pharmaceutical industry to comply with the new GMP requirements. The 7 mechanisms mentioned above, especially factor 3, 4 and 5, will sure facilitate an industry reshuffle to a great extent.

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