The Five Case Will No Longer Be Registered In The Chinese Drug Knockout Tournament.

Recently, the official website of the State Administration of drug administration released 9 major draft opinions covering the registration, re registration, post marketing clinical changes, and production and circulation of drugs, biological products and Chinese medicines covering the territory and abroad.

The above documents, as the supporting documents of the "drug registration management regulations", which will be formally implemented in July 1st, further clarify the definition of innovative drugs, such as chemical drugs, biological medicine and Chinese medicine.

The relevant supporting documents will have a great impact on the entire pharmaceutical industry. Among them, in the draft of the relevant regulations on drug re registration, there are 5 kinds of non registration of drugs for domestic and overseas production. In Beijing Ding Chen medical management consulting center Shi Lichen seems to re registration as an opportunity for a large number of drugs will be phased out.

A listed pharmaceutical company official pointed out that a lot of drugs that had not been produced for a long time were not cancelled. Some drugs with inaccurate effects and large adverse reactions were sold in the market even in foreign countries, and the drugs that were restricted were sold. They also occupied the share of the national medical insurance.

The five case will no longer be registered.

Drug re registration refers to the application for registration of the production or importation of such drugs after the expiration of the drug approval documents. The original state drug administration promulgated the "Regulations on drug registration administration" (Trial Implementation) (Bureau order No. thirty-fifth). For the first time, the concept of re registration of drugs was clearly put forward, indicating that the policy of drug re registration in China has entered a unified and perfect stage.

In recent years, the definition of drug re registration is also changing. But in twenty-first Century, the economic report combing reporters found that from December 10, 2019, the State Administration of market supervision and Administration issued a notice on public consultation on drug registration management (Draft), it was clear that the drug re registration system: drug registration certificate valid for 5 years. Some people should continue to ensure drug safety, effectiveness and quality controllability, and apply for registration of drugs 6 months before the expiry date.

The draft of this edition and the newly issued drug registration management procedures are completely identical in procedure. There are two main changes in the registration procedures with the existing registration procedures. First, the main body is the holder of the license for drug marketing, and second, the re registration certificate is no longer issued, but the "drug re registration approval notice" is issued.

In addition, in the draft of the relevant regulations on drug re registration, there are 5 kinds of registration that are not registered for the production of drugs inside and outside the country.

    Specifically, the application for reregistration is not specified at the expiration of the term of validity; the holder can not fulfill the duty of continuing investigation of the quality, efficacy and adverse reactions of the drug during the period of validity of the drug registration certificate; there is no reasonable reason for the failure to complete the drug approval documents and the requirements of the drug supervision and administration department within the prescribed time limit; after the listing, the evaluation is not accurate and adverse. It should be harmful to human health due to other reasons or other reasons.

Judging from the above situations, the regulatory authorities pay more and more attention to the quality, efficacy and adverse reactions of drugs. This is also in line with the newly revised "Drug Administration Law" requirements, the effect is not accurate, adverse reactions, or other reasons for human health hazards, will be canceled drug registration certificate.

The above problems are directly related to the quality and safety of medicine. The state has been paying close attention to it. Taking adverse reactions as an example, the state will issue relevant reports every year. For example, in April 10th, the national adverse drug reaction monitoring annual report (2019) released by the National Center for adverse drug reaction monitoring showed that in 2019, the national ADR monitoring network received 680 thousand reports of adverse reactions / events in the catalogue. The reports were related to chemicals and biological products. Accounted for 89.5%, proprietary Chinese medicine accounted for 10.5%.

According to official data from the State Administration of drug control, the number of approved drugs has reached over 16. The head of a listed pharmaceutical company explained to the economic news reporters in twenty-first Century that there had been a lot of reductions in the past two years, but the total amount was still very large. This is related to the over declaration of many domestic drug varieties, the historical reasons and the environment of the Chinese pharmaceutical market, the licensing of drug production and the low cost of drug registration.

Among them, the mechanism of withdrawal and re registration is not clear, so that many long-term non production drugs have not been written off. Some drugs that are ineffective, adverse reactions, and even have been banned and restricted in foreign countries are sold, and occupy the national medical insurance quota.

Elimination tournament opens

    In addition to combining the foreign pharmacovigilance reports and the domestic adverse drug reaction monitoring, the SFDA has intensified the dynamic evaluation and adjustment of drugs in recent years. By revising the instructions, etc., for example, in March, the National Drug Administration issued a bulletin on the instructions of 3 commonly used drugs, paracetamol, Compound Liquorice Tablets and diclofenac sodium suppository. Changes include increased adverse reactions, increased warnings, and increased use of drugs by special populations.

At the same time, in Shi Lichen's view, the consistency evaluation advocated by the state is actually aimed at improving the quality and safety of drugs, which is also the designated action of pharmaceutical companies.

As of May 3, 2020, a total of 827 product regulations passed (or passed through) conformance assessment, involving 269 varieties.

According to the twenty-first Century economic report, according to the incomplete announcement of the listed company's announcement, as of April 30th, the listed companies had passed the conformance evaluation of the research and development expenses, including the total adoption of the drugs, including 149, and the 43 conformance evaluation fees were equal to or higher than 10 million yuan. Among the 18 drugs that were approved, 11 were equal to or higher than 10 million yuan, among which, the cost of consistency evaluation of acetic acid in the medicine of Heng Rui pharmaceutical was 39 million 50 thousand yuan.

Guotai Junan pointed out that the conformance evaluation of competition pattern has become the most important variable in the national gathering pattern. "A large number of capacity may withdraw from the market because of failure to pass the conformance evaluation as required. The market share will be concentrated. More and more varieties will be produced, and prices will spiral downward under competition. The profit margins of generic drugs will also gradually narrow down, and the valuation center of generic drugs companies will move downward.

For generic drugs, according to the relevant requirements, after the consistency of the self confession varieties, the other varieties of drug manufacturers should complete the consistency evaluation within 3 years in principle. Overdue completion is not a clinical necessity. The market short variety will face the fate of not re registering and eventually delisting.

Re registration has become the critical point for large numbers of drugs to be eliminated. In order to sustain development, enterprises are also actively re registering drugs.

For example, the North Lu pharmaceutical company has recently obtained 6 drug re registration products approved by the Beijing Municipal Drug Administration, including Iopamidol Injection (50ml:18.5g (I)), Iopamidol Injection (50ml:15g (I)), Iopamidol Injection (100ml:30g (I)), Iopamidol Injection (100ml:37g (I)), Glimepiride Tablets (1mg), Glimepiride Tablets (2mg).

The North Lu pharmaceutical company said that the re registration of the above drug approval documents ensured the stability and continuity of the sales qualification of the above drugs, which has positive significance for the sales and promotion of the above products.