Regulation of Pharmaceutical Production will be Stricter with the Cancellation of GMP Certification in China

The Amendment of the Drug Administration Law of the People's Republic of China (Draft for Comment) proposes to cancel the GMP certification and GSP certification, and change the APIs and excipients to be approved together with pharmaceutical products. In this regard, according to the analysis of an observer, it will make pharmaceutical enterprises harder to cheat in workmanship or material or operate illegally by transforming from stressing threshold to stressing supervision, and increasing frequency of supervision means like “unannounced inspection” in the daily production and operation of pharmaceutical enterprises.

The Drug Administration Law will undergo big changes, to cancel the GMP certification, and legalize the transfer and sales of the pharmaceutical product approval numbers. The China Food and Drug Administration (CFDA) has recently issued the Amendment of the Drug Administration Law of the People's Republic of China (Draft for Comment), and expressed that this amendment surrounded closely the Opinions on Deepening the Reform of the Review and Approval System and Inspiring Innovation of Drugs and Medical Devices issued by the General Office of the Communist Party of China Central Committee and General Office of the State Council of China this month, and proposed 36 reform measures.

The reporter discovers that the Draft for Comment is embodied as encouraging innovation, increasing punishment, and transforming from stressing threshold to stressing regulation.

Encouraging innovation by permitting transfer of pharmaceutical product approval numbers
According to the CFDA, only a part is amended this time, and feedback and suggestions may be sent by October. The reporter notices that this Draft for Comment defines that the applicants to obtain pharmaceutical product approval numbers are the marketing authorization holders who may produce and operate pharmaceutical products on their own or entrust others for the production and operation. “Changing the marketing authorization holder shall comply with conditions specified herein, and be approved by the pharmaceutical product administration of the State Council”.

According to an industry observer, this opening means that the product approval numbers may be transferred according to law, instead of being unmovable like it used to be.

 “This helps accelerate the market liquidity, not causing pharmaceutical product approval numbers to be wasted and left unused by a certain pharmaceutical enterprise.” And according to the analysis of a relevant person of a pharmaceutical enterprise, the reform of the marketing authorization holder is to activate innovation as well as resources, for example, sci-tech workers of R&D institutions can have own pharmaceutical product approval numbers; furthermore, the production and marketing authorization can be effectively separated, and the resource mobilization will be more flexible.

However, he also stressed that the sales (of the approval numbers) according to law are permitted, but products should be strictly checked from source, leaving factory, to after sales with the whole process traceable, no matter for self-production or entrusted operation.

Regulation to be stricter with cancellation of GMP certification
The Draft for Comment also proposes to cancel the good manufacturing practice (GMP) certification and good supply practice (GSP) certification, and change the APIs and excipients to be approved together with pharmaceutical products; it also changes the certification of clinical trial institutions to filing thereof, changes the drug clinical trial approval from express permission to implied permission, and requires the bioequivalence tests to be implemented filing management.

In this regard, according to the analysis of an observer, GMP certification was previously thought to approve the operation after obtaining the certificate, however, many pharmaceutical enterprises begin to relax after obtaining GMP certification by all manner of means, so that the regulator has to use great efforts every year to investigate and revoke GMP certificates of enterprises breaking law. However, it will make pharmaceutical enterprises harder to cheat in workmanship or material or operate illegally by mentality transforming from stressing threshold to stressing supervision, and increasing frequency of supervision means like “unannounced inspection” in the daily production and operation of pharmaceutical enterprises.

Heavy punishment for data fabrication: prohibited from engaging in the industry for 10 years
The Draft for Comment also particularly stresses the requirement of implementing punishment to specific person. Units that have information or data fabrication and are revoked license and the directly responsible supervisor and other direct responsible personnel thereof will be prohibited from engaging in the industry for ten years; personnel who are sentenced to set term of imprisonment and above due to crimes in terms of pharmaceutical product safety shall not engage in the R&D, production, operation, and import and export of pharmaceutical products in their lifetime.

If any marketing authorization holder, developing unit, manufacturing enterprise, operating enterprise, or medical institution deliberately commits the offence or has gross negligence, or their offence is serious or of a vile nature, or causes serious consequences and other serious bad social influences, the directly responsible supervisor and other direct responsible personnel thereof will be fined 30% to 100% of the income obtained from the unit in the previous year.

According to an observer, the data fabrication has been seriously investigated in recent three years. The clinical data fabrication must be strictly investigated and heavily punished because pharmaceutical products are special commodity and any clinical data fabrication may cause health risks to large numbers of people.

Source/author: Guangzhou Daily/Tu Duanyu