By Huang Jianwen King & Wood Mallesons’ Commercial & Regulatory group
In order to deepen the reform in the field of drugs, the China Food and Drug Administration (“CFDA”) issued the Drugs Administration Law (Draft for Consultation) (“Draft”) on 23 October 2017. The Draft incorporates and reflects material contents in the reform of drugs field in recent years, including fully implementing the Marketing Authorization Holder (“MAH”) system, cancelling certificates of Good Manufacturing Practice (“GMP”) and Good Supply Practice (“GSP”), carrying out records management for clinical trial institution and emphasizing legal liabilities on relevant entities in drug research and trial.
Continue Reading Analysis on the Drugs Administration Law (Draft for Consultation)