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New Approval Process for Medical Devices and Drugs Introduced by China

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Published on : Dec 08, 2015

New approval procedures for medical devices and drugs from China will welcome new opportunities for the companies operating in the medical devices sector. Companies will be able to explore new drug development opportunities to add innovations in drugs in China and other countries as well. The China Food and Drug Administration (CFDA) announced new rules and procedures for registration of drugs and medical devices in order to speed up the approval system and regulatory review system for pharmaceutical products. With the new procedures, CFDA aims in removing any blockage of applications for registration of drugs and medical devices in China. 

With the announcement of new procedures and policies, CFDA plans to improve the approval and appraisal process by expanding fast track procedures. The new procedures are designed to streamline the approval system and regulatory review system for specific kinds of drug registration. Furthermore, it will also enforce severe punishments on any parties or individuals involved in the fabrication of any clinical data. 

From 1st Dec 2015, the fast track approval process includes broader category of drugs such as innovative drugs that are approved abroad but are to be manufactured in China, drugs that are manufactured at Europe and the U.S., drugs urgently required for clinical trials, drugs to treat malaria, HIV, severe infectious diseases, and malignant tumors, and drugs that are listed in the national key research and development plans. 

Other improvements that are promised by the CFDA are changing the classifications of generic and novel drugs, improved approval and appraisal of clinical trials, and centralized appraisal of drugs. Under the new procedures, there are plans to classify the pharmaceutical products that are marketed away from China so that they will be applicable for approval. Expansion of the approval procedures for the medicines that have been marketed outside China are similar to the approval procedures in New Zealand and Singapore.