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CFDA released its 100th announcement on 25th, August, the consistency evaluation of generic drug were unscrambled, which reignited the market of excipient.

 

 [Article 13 - Clause 3]:

For the generic drugs that are manufactured in China and approved by the EU, USA, or Japan which have already been launched in the Chinese market and plan to produce on the same product line and prescription process, the manufacturers must fill in and submit the supplementary application of the drugs, and specifically state either “application of consistency evaluation in collinear production, with the changes on the production line or prescription process” or “application of consistency evaluation in collinear production, without changes on the production line and prescription process”. The submission of application documents should correspond to the requirements of Article 9 and Article 13-Clause 1 in this announcement. If the packaging material manufacturers can not provide the legal certificates of origins for their packaging materials which used for packaging APIs, excipients and direct contact drugs, they must submit a legal usage declaration of these packaging materials already been used in EU, USA, and Japan markets (or submitted by the pharmaceutical companies) and the explanation of can’t provide relevant technical documents for these packaging materials. The pharmaceutical companies should submit the relevant research documents, the related explanation and the conclusion of consistency evaluation should be released to the public.

 

This announcement declaims the materials that are used legally abroad, can be used in China in the future. For pharmaceutical manufacturers that export to Chinese market, they should improve their producing standards, as the foreign excipient suppliers can make significant mutual benefits. For the imported excipients that have not been registered yet China, will soon be unban for the Chinese market. At the same time, this announcement opens a wide door for these imported products into the Chinese market.

 

The PHAEMEX of Reed Sinopharm Exhibitions is the flagship exhibition of pharmaceutical excipient in the Asia-pacific region, which will attract 50,000 elites of pharmaceutical industry to share their experiences and knowledge to improve the Chinese medicine quality. For now we have attracted many Chinese and overseas excipient manufacturers to attend the exhibition, such as Colorcon, Merck, Ashland, Gattefosse, DFE, Kerrygroup, ShinEtsu, and other top-ranking international pharmaceutical enterprises are well-prepared for the opening of this exhibition.