Firstly, unannounced inspection will undoubtedly play an increasingly important role in supervision of this year and even the following years. In the 26th China Medicine Economic Information Conference ended in November 2014, Wu Liya, from Department of Legal Affairs, made a report titled Introduction of Revision Situation of Drug Administration Law to introduce the latest development and overall thinking of revision situation of Drug Administration Law.
Secondly, governing by law is the most concerned topic of the drug administrations on the premise of ruling country by law, after unannounced inspection becomes more frequently and stricter. Viewed from departments and bureaus participating in the charrette, i.e., the principal of Department of Legal Affairs, the Department of Drug and Cosmetics Supervision, Department of Drug and Cosmetics Registration, Bureau of Investigation and Enforcement as well as Center for Food and Drug Inspection, covering main departments for drug administration; this charrette, which brought those main departments for administration and legal professionals together, was obvious to discuss the investigation methods as well as problems in the investigation with the legal professionals, and to discuss the legitimacy and compliance, wherein, secret inquiry was a focus in this charrette.
Thirdly, viewed from the unity of CFDA and judicial professionals this time, the future inspections of CFDA and provincial administrations may conduct joint law enforcement with the public security and administration for industry and commerce, etc., therefore, illegal acts and violations may be subject to more seriously punishments in the future.
After unannounced inspection becomes normal and strict, the quantity of substandard pharmaceutical enterprises whose GMP certificate are taken back is estimated to increase. With such frequent unannounced inspection, is it the time when the industry reshuffle comes?
