China's "New Law" tightens safety and quality management

Regulation tightens specifically for clinical institute, GMP and GSP and illegal practices

China is to reinforce overall pharmaceutical management and monitoring regulation covering from pharmaceutical production, launch, clinical trial to counterfeit drug.

 

The so-called ‘New Drug Administration Law’ would mainly focus on safety and quality.

 

China’s National Medical Products Administration (NMPA) had taken the revised law in effect from last month.

 

Considering the time it needs to settle in with the entire system, the new law would be enforced from the beginning of this year.

 

The revision consists of pharmaceutical marketing authorization holder system, clinical trial institute record management, Good Manufacturing Practice (GMP) and Good Storage Practice (GSP) management, review and approval on chemical ingredient, and tightened investigation and prosecution over illegal practice.

 

First, the Drug Marketing Authorization Holder (MAH) system has been toughened stringently.

 

The system stipulates a pharmaceutical company or manufacturer, with registration number-marked drug registration certificates and imported drug registration certificate, should strictly perform the MAH obligations.

 

The authorization holder has liability for the entire life-cycle of a drug from development to production and management to ensure drug safety, efficacy and quality.

 

The new law also tightened clinical trial institute’s record management.

 

The Chinese regulator has adopted a form of pre-management system that would process clinical trial institute certification according the regulation, if it has not been completed before last December.

 

The revised law would also strictly regulate GMP and GSP certification.

 

A company cannot apply for the certification if charged with illegal practice in R&D, production or management, and the Chinese regulator would also conduct on-site audit as stated by the regulation.

 

And the regulator’s review and approval for chemical ingredient manufacturer would be integrated within the existing registration procedure.

 

Each regional regulatory authority has to ultimately enhance drug safety effectively by strictly following the said regulation and also by stringently imposing penalty on illegal practice.

 

The Chinese government plans to promptly set and announce further details of the New Drug Administration Act.