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TWN Info Service on Intellectual Property Issues (Jan17/01)
18 January 2017
Third World Network


Dear friends and colleagues,

China approves generic version of three vital medicines

The China Food and Drug Administration (CFDA) announced in its press release on 12 January 2017 that it recently approved the registration applications of the generic versions of three medicines:

(i) Gefitinib tablets for cancer treatment,

(ii) antiviral Efavirenz tablets for HIV/AIDs, and

(ii) Tenofovir disoproxil fumarate (TDF) tablets for HIV/AIDs.

(TDF can also be used for hepatitis B treatment.)

These products are commonly used drugs related to the first line treatment of the diseases concerned.

The approved generic versions of Gefitinib manufactured by Qilu Pharmaceutical (Hainan) Co. Ltd, Efavirenz by Shanghai Desano Bio-Pharmaceutical Co. Ltd, and TDF by Chengdu Brilliant Pharmaceutical Co. Ltd are the successful set of such medicines for China’s domestic market. According to CFDA the quality and efficacy are basically the same as that of the original versions. CFDA at the same time approved the marketing of the Active Pharmaceutical Ingredients (API) of the three medicines so that the localization from API to final products can be achieved.

Since the beginning of the year 2016, CFDA has prioritized approval of the registration applications of the innovative medicines for prevention and treatment of HIV/AIDs, cancer, major infectious diseases and rare diseases and other medicines that are clinically urgently needed. As of the end of December 2016, CFDA has announced 12 approved batches of prioritized medicines that involved 191 registration applications. CFDA will continue to strengthen support for the registration of medicines of obvious clinical value and for treatment of major diseases such as HIV/AIDS to encourage innovation, improve quality and enhance medicines safety and accessibility for patients.

For more information, please refer to the press release of CFDA in Chinese at http://www.sda.gov.cn/WS01/CL1033/168506.html.


With best wishes,

Third World Network

 


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