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“4+7” quantity procurement is expanded. The State Food and Drug Administration checks the pharmaceut

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The GMP and GSP certifications were cancelled, and the SFDA was inspecting pharmaceutical companies and drug dealers at any time.

The drug selection in the procurement of quantity is stricter.

▍The State Food and Drug Administration, at any time, to inspect pharmaceutical companies and drug dealers

A few days ago, the State Food and Drug Administration issued a notice on the study and promotion of the "People's Republic of China Drug Administration Law" (Chinese Medicine Supervision Law [2019] No. 45).

 

Notify all drug regulatory authorities across the country: After canceling the Good Manufacturing Practice (GMP) certification and the GSP certification, the regulatory authorities should check the implementation of GMP and GSP at any time.

Strengthen dynamic supervision, rectify chaos, and severely punish violations.

▍ Certified cancellation, professional inspection team came

On August 26, the Standing Committee of the 13th National People's Congress voted to approve the amendment of the Drug Administration Law of the People's Republic of China, confirming the cancellation of GMP/GSP certification. The newly revised Drug Administration Law will be implemented on December 1, 2019.

Although there is no longer GMP/GSP certification, the drug production license and business license will be checked together in the future. According to the deployment of the State Food and Drug Administration at any time, the supervision of the company is actually stronger.

On July 18, the General Office of the State Council issued the "Opinions on Establishing a Team of Professionalized Specialized Drug Inspectors", and established a team of professional specialized drug inspectors to further improve the drug regulatory system. In recent years, after the normalization of the flight inspection, the state attaches great importance to professional and professional drug inspections, which will put more pressure on violations and violations of laws.

In fact, the supervision in recent years is getting bigger and bigger. According to statistics, the State Food and Drug Administration organized and reported 37 drug inspections in 2018, an increase of 8 times compared with 29 in 2017. The number of flight inspections continued to increase.

The procurement will be more strict with the purchase of drugs.

For the inspection of pharmaceutical companies at any time, it will be stricter after the 4+7 expansion.

Many people know that the price of the 4+7 national expansion of the selected drugs has dropped a lot, which has also caused the industry to worry about the quality of the drugs. Although based on normal logic, the selected drug companies are unlikely to do the drug quality. Article, but as a regulator, it is inevitable to increase the intensity of its inspection.

There are authoritative experts predicting that the guarantee for the quality of the selected drugs lies in supervision. The next step in the supervision of drug quality may be a focus of the national system of the drug regulatory department.

In fact, this is not difficult to understand. As an unprecedented purchase, it is a big move for Huiji people's livelihood. It is absolutely not allowed for pharmaceutical companies to reduce the quality of drugs and reduce costs to obtain a market at a low price. For strict supervision, relevant pharmaceutical companies must also have Psychological preparation.

The source is strictly guarded, the process is strictly controlled, and the risks are strictly controlled. The purpose of inspection at any time is still the constant theme of ensuring drug safety.