GMP Certificate Cancelation: Concern Or Relief?
GMP Certificate Cancelation: Concern Or Relief?
GMP Certificate Cancelation: Concern or Relief?
Claire Gu, European-American Desk
On September 24th, Ding Jianhua, director of the China Food and Drug Administration (CFDA) Supervision Department, stated at the 2017 Chinese Pharmaceutical Entrepreneurs, Scientists and Investors Convention that the Good Manufacturing Practices (GMP) certificate would be cancelled. This statement can be taken as a signal of an official confirmation to cancel the GMP certificate. This news quickly went viral and sparked uproar.
The cancelation of the GMP certificate is disheartening. It is undeniable that in the past 20 years, China's pharmaceutical industry would not have made any notable achievements without the GMP certificate, during the course of pharmaceutical development. Over the years, GMP has regulated pharmaceutical companies in every aspect, including factory plant, equipment, personnel training, hygiene, air and water purification, production, and documentation.
GMP obliges drug regulatory departments to inspect drug manufacturers for their compliance with GMP’s requirements, in accordance with the relevant provisions, and issue a certificate to the manufacturers who have passed the inspection. Without the GMP certificate, drugs will not be allowed to enter the market.
Since then, the GMP certificate has been in the spotlight. In 2016, 170 GMP certificates belonging to 162 pharmaceutical companies were revoked, indicating that some pharmaceutical companies had their certificates revoked more than once.
Nevertheless, the issue today is that GMP certificate has strayed away from its initial purpose. Currently, passing an inspection will win the pharmaceutical company a 5-year certificate.
Upon obtaining the certificate, companies then prefer to sell the production to the wholesaler, making it difficult to link the patients with the production quality, because the companies then lose control over production. This process somehow prompts companies to act irresponsibly.
In reality, signs of cancellation date from 2013 when the General Office of the State Council issued the <Circular on issuing the main responsibilities of internal institutions and staffing requirements of CFDA >, which proposed the concept of “two certifications become one certification.” It suggested “making the pharmaceutical production administrative license and GMP certification gradually integrated into one administrative license; making the Pharmaceutical Production Trading License and GSP Certification gradually integrated into one administrative license.”
Consequently, the word “cancel” has repeatedly been cited by different government officials on various occasions.
New wine in old bottles
Although phrased differently, the document did not bring major changes to the pharmaceutical industry. In fact, GMP refers to “basic requirements” rather than “highest requirements”. Obtaining a GMP certificate does not guarantee production quality or high standards within the company.
There are many rules that are more significant than the GMP. For instance, a thorough quality management system, quality awareness, risk management, quality experience, not to mention other specific CMC requirements for the process, like prescription, raw materials, and control measures when going through the registration procedure. Quality management should center on the patient instead of focusing on inspection.
Many people think it is only an administrative measure to follow the “streamline administration and institute decentralization” instruction. Recently, the State Council has been abolishing unnecessary approvals and licenses. Tired of certification and recertification, many companies are hoping for a more flexible environment.
Cut off one certificate, two more inspections shall take its place
The other side of the coin reveals a different story. Some industry insiders believe that the GMP/GSP certificate carries weight. Specifically, before entering the market, drugs need to be produced under sales management. GMP is still recognized as the international norm by the WHO. GMP is a prerequisite for entry into the international market.
In fact, there is no way for a competent authority to exempt pharmaceutical companies from all liabilities and more stringent criteria must be laid down. It can be predicted that there will be more unannounced inspections of drugs and medical devices and unannounced supervision and inspections by the food and drug administrative departments over the R&D, production, operation, use, and other aspects of drugs and medical devices. The inspection methods will most likely be more diverse.
To better illustrate this situation, we could use the following comparison: if a company with a certificate was a student who has received admission to college, it should still remain motivated to work hard and obtain good grades.
It has been a wild period for pharmaceutical companies due to the two-invoice system, medical representative recording system, and other unexpected changes, and unfortunately the road looks even bumpier ahead.
