By Ming Q. Lu
This authoritative quantity examines the foremost legislation, laws and guidance on the topic of pharmaceutical product improvement in China. With a spotlight on patent, medical and registration techniques, the ebook is helping Western businesses introduce their medical medicinal drugs to the chinese language marketplace, be sure a strategic direction and bridge the distance for regulatory and criminal adjustments among China and the Western global. For a greater knowing of the drug registration procedure, it explores the variations among the China nutrients and Drug management (CFDA)—including its laws and registration procedures—and these of the Western international. the amount discusses disparities among China's program requisites in comparison to Western criteria to make it more straightforward for corporations to arrange their software programs. It additionally offers precise statement on CFDA directions in connection with medical trial (IND) and industry software (NDA) specifications. total, this booklet deals counsel for Western businesses intending to extend into China’s pharmaceutical industry in hopes that they could achieve a basic knowing of its ideas and complexities with the intention to be certain a soft transition and forestall destiny issues.
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Extra resources for Approaching China's Pharmaceutical Market: A Fundamental Guide to Clinical Drug Development
For details, please also see the appendix 2—MEASURES FOR THE CONTROL OF NARCOTIC DRUGS Article 36 The State Council shall formulate detailed measures to carry out a protection system for the categorization of traditional Chinese medicines. Article 37 The State Council shall formulate detailed measures to carry out a classified control system for prescription pharmaceuticals and non-prescription pharmaceuticals. Article 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people’s health shall be prohibited.
In this case, the enterprise in question must report to the local province, autonomous region, or municipality directly under the central government and drug supervision and management departments and the public health administrative department in a timely manner. The “serious adverse reaction” mainly includes: 1. death caused by taking the drug; 2. cancer or birth defects caused by taking the drug; 3. damage to vital organs, life threatening or loss of normal life ability caused by taking the drug; 4.
Pharmaceutical producing enterprises shall use the packaging materials and containers which have direct contact with the pharmaceuticals only after they have obtained approval for them. The pharmaceutical supervisory and administrative departments shall stop the use of those unqualified packaging materials and containers which have direct contact with the pharmaceuticals. 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.
Approaching China's Pharmaceutical Market: A Fundamental Guide to Clinical Drug Development by Ming Q. Lu