According to the news on CFDA official website recently, CFDA organized and drafted Methods for Unannounced Inspection of Pharmaceutical Products (Draft) (hereinafter referred to as the Methods) in order to strengthen the prevention and control of pharmaceutical product safety and risk, investigate and penalize illegal activities regarding pharmaceutical products according to law.
On January 7, 2015, CFDA Department of Legal Affairs jointly with Department of Drug and Cosmetics Supervision organized and convened a charrette in Beijing, and invited the Supreme People's Court of the P.R.C., Higher People's Court of Beijing, Beijing No. 1 Intermediate People's Court, Beijing NPC Legislative Affairs Office, China University of Political Science and Law as well as expert, scholar and legal adviser from Zhongzhao Law Firm to discuss the difficult problems in the draft. Principal of Department of Legal Affairs and relevant staff from 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 attended the charrette.
Experts conducted an in-depth discussion regarding nature and orientation of unannounced inspection, acquisition of law enforcement qualification of inspectors, conversion and use of evidences collected during the inspection in the administrative punishment, and legitimacy of secret inquiry, etc. Furthermore, experts also proposed valuable opinions and suggestions for enhancing maneuverability of regulations, detailing situations of enterprise not cooperating with inspection, seriously handling disciplinary violations of supervisors and strengthening authority of law enforcement, etc.
This charrette expanded supervision thinking, clarified difficult problems and provided basic protection for legislation according to law and scientific legislation.
