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The era of the strictest drug regulation is coming.


At the launching ceremony of the National Safe Drugs Month in 2019, Cypress learned that from January to September this year, the Verification Center has completed the verification of 163 varieties of clinical trial data and 177 varieties of pharmaceutical production site inspections, and also on 27 In 151 varieties, 153 varieties of drugs were used for on-site inspection of pharmaceutical production - a total of 331 varieties, which have been inspected by the verification center to ensure drug safety.

▍ 177 overrated varieties, verified

On October 17, the 2019 National Safe Drugs Month Launching Ceremony hosted by the State Drug Administration and hosted by the China Pharmaceutical Association and People's Daily Health Channel and the 4th China Drug Safety Forum were held in Beijing.

Cypress Blue was informed at the scene that Wang Xiaogang, director of the Food and Drugs Inspection and Inspection Center of the State Drug Administration, disclosed a set of data: In recent years, we have carried out on-site inspections of pharmaceutical production in 172 varieties in 27 countries, including 21 The variety was announced, and it was suspended from importing, stopped selling and using, and was not re-registered and other administrative treatments. After 20 varieties were informed that they were listed for entry and exit, the company took the initiative to withdraw, retired, or even gave up the variety number. .

This means that the overseas inspection of drugs is constantly increasing, effectively stopping the problem drugs from outside the country.

In addition, as one of the key tasks of the review and approval of drug medical device review and approval, the progress of consistency evaluation has been widely concerned by the industry. According to public information, as of now, a total of 222 varieties (in terms of common name + specifications) have passed, and the number of 35 varieties passed has reached 3 or more. Among them, Qilu Pharmaceutical has the most evaluation varieties, a total of 26; a total of 11 companies have passed at least 10 varieties through the consistency evaluation.

The quality stability and homogeneity of generic drugs are insufficient compared with the original research drugs. If the supervision level is not enough after the listing, and “only low prices are taken”, it may force enterprises to cut corners and control costs, and become a “one-time evaluation”.

In order to prevent the occurrence of drug quality and efficacy risks, the verification center shall, in accordance with the requirements of the State Food and Drug Administration, prioritize the allocation of inspection resources, improve the inspection procedures, and ensure that the consistency assessment inspection tasks are completed in accordance with the time limit and high quality. Saibailan learned that from January to September this year, the verification center has completed the verification of 163 varieties of clinical trial data and 177 varieties of pharmaceutical production site inspection.

Judging from the above data, in the past six months of 2019, the supervision of drugs has been increasing. Under the background of the Party Central Committee and the State Council attaching great importance to drug safety, it will be undoubted that the supervision of the drug life cycle will be strengthened in the future.

▍ The most stringent drug regulatory era, coming

Since the 18th National Congress of the Communist Party of China, the Party Central Committee with Comrade Xi Jinping as the core has attached great importance to the construction of professional drug inspectors for drug supervision and professionalization. In July 2019, the General Office of the State Council issued the "Regulations on the Establishment of Professionalized Specialized Drugs. The Opinions of the Staff Team, it is planned that by the end of 2020, the drug regulatory department of the State Council and the provincial drug regulatory authorities will basically complete the construction of a system of professional professional drug inspectors.

It is understood that professional inspectors of specialized chemical drugs (including medical devices and cosmetics) refer to those who have been confirmed by the drug regulatory authorities to conduct compliance verification and risk judgment on the places where the management counterparts engage in drug development, production, etc. Strengthen the important support of drug supervision and drug safety.

In other words, the drug regulatory authorities hope to establish a team of high-quality, exquisite, clean and efficient drug inspectors, thereby increasing the intensity of violations of laws and regulations in the development, production, operation and use of drugs.

In the recently revised Drug Administration Law, it was also confirmed that the GMP/GSP certification was cancelled, which means that the pre-approval supervision model has gradually transformed into a dynamic post-event supervision and full life cycle supervision. The model has been basically established.

The "2018 Annual Report on Drug Supervision Statistics" shows that in 2018, the regulatory agencies at all levels investigated and handled 98,000 drug cases, with a value of 2.74 billion yuan, a fine of 7.66 billion yuan, confiscation of illegal proceeds of 2 billion yuan, and the abolition of 1037 households without licenses. 148 smashed fake and fake sales dens, ordered 1093 suspensions of production and business suspension, revoked 197 permits, and transferred 2,000 judicial organs.

This shows that the country's frequency of flying inspections, the establishment of a professional team of drug inspectors, and the strengthening of penalties for violations of laws and regulations, as the industry analysis pointed out: the most stringent drug regulatory era is coming.

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