By Ming Q. Lu
This authoritative quantity examines the foremost legislation, laws and guidance regarding pharmaceutical product improvement in China. With a spotlight on patent, scientific and registration innovations, the ebook is helping Western businesses introduce their medical medicinal drugs to the chinese language industry, ensure a strategic course and bridge the space for regulatory and felony ameliorations among China and the Western international. For a greater realizing of the drug registration strategy, it explores the diversities among the China nutrients and Drug management (CFDA)—including its laws and registration procedures—and these of the Western international. the quantity discusses disparities among China's program necessities in comparison to Western criteria to make it more uncomplicated for corporations to organize their software programs. It additionally presents particular statement on CFDA instructions in connection with scientific trial (IND) and marketplace software (NDA) requisites. total, this ebook bargains assistance for Western businesses meaning to extend into China’s pharmaceutical marketplace in hopes that they could achieve a primary realizing of its ideas and complexities so as to make sure a tender transition and forestall destiny issues.
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Extra info for Approaching China's Pharmaceutical Market: A Fundamental Guide to Clinical Drug Development
Those whose acts constitute a crime shall be investigated for criminal liabilities. Article 83 Those who violate this Law by providing false certificates or samples of documents, or obtaining the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations or pharmaceutical approval certificates through cheating, shall have their Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations revoked, have their pharmaceutical approval certificates revoked, have their application rejected for 5 years, and have a concurrent fine of more than 10,000 but less than 30,000 RMB be imposed upon them.
Interpretation: This article is about the direct contact with the drug packaging materials and container management system. See “Examination and approval for import of packaging materials and containers in direct contact with drugs” for more d etails. Article 53 Packaging must meet the specific quality requirements of the pharmaceuticals and facilitate their storage, transportation and medical use. Traditional Chinese medicinal materials must be packaged before transportation. There must appear on the package the name of the medicine, place of production, date, name of the consignor, and an indication showing that the quality of the medicine meets standards.
Article 59 Pharmaceutical producing enterprises, trading enterprises and medical organizations are prohibited to give or receive secret commissions and other benefits during the purchasing and selling of pharmaceuticals. Pharmaceutical producing enterprises, trading enterprises or their representatives are prohibited to give any property or other benefits under any name to the principals, buyers of pharmaceuticals, physicians and other relevant persons in the medical organizations where their pharmaceuticals are used.