National Food and Drug Administration issued new regulations for generic drugs

A new round of shuffling is underway in the generic pharmaceutical industry. On the 23rd, the official website of the State Food and Drug Administration (SFDA) released the Work Plan for the Quality Conformity Assessment of Generic Drugs (Draft for Soliciting Opinions) (hereinafter referred to as the “Programme”), stating that the quality consistency assessment of generic drugs will be launched and eliminated. The intrinsic quality does not meet the required variety. The “Programme” clearly stated that in 5 to 10 years, the generic drugs approved before the implementation of the “Drug Registration Regulations” revised in 2007 must be batch-phased in batches with the quality of generic drugs (ie, “original research drugs”). The evaluation made the generic medicine and the generic medicine reach the same level.

Some medical experts said that the vast majority of chemical products approved for listing in China are generic drugs, but the quality of some generic drugs is far from the generic drugs, affecting the clinical efficacy of generic drugs to some extent, and even affecting consumer drug safety. . "Once the consistency assessment is fully implemented, the domestic general pharmaceutical companies may usher in a new round of reshuffling."

7,000 generic drugs are monitored as generic drugs, which have the same therapeutic effects, active ingredients, dosage forms, and alternative routes of administration as generic drugs and have the advantages of reducing medical expenses. The data shows that there are more than 16,000 kinds of drugs that China has approved for listing, and the number of drug approvals is 187,000, among which there are 77,000 kinds of chemical drugs and the number of approvals is 121,000. The vast majority are generic drugs.

With the development and implementation of the new medical reform, the demand for quality of medicines has gradually increased. The quality problems of generic medicines have become increasingly prominent. In the bidding of drugs, using price as a measure has led to the tendency of “only low prices are taken”, which has a great impact on corporate profits.

“This is the first time that officials have shown that there is a quality difference in generic drugs.” According to sources close to SFDA, the official attitude was that the generic drugs were only qualified and unqualified, and now they have gone deep into the quality of qualified drugs. This is a big step forward.

Wu Hao, the deputy director of the State Food and Drug Administration, has repeatedly demanded that generic drugs must be “identical” to the generic drugs, that is, they must be “imitation drugs”, not just “imitation standards”, and require the quality of products and original research drugs to be internalized. Consistency in the production process, therapeutic effects, etc. cannot be distorted. According to the news from the SFDA Registration Department, “At present, the SFDA and related ministries and commissions are working on the discussion and research work on the consistent evaluation of relevant technical standards, and will eventually be issued as a programmatic document”.

Persons who are close to the SFDA as the first target for oral solid preparations stated that according to the SFDA's schedule, a list of reference preparations will be established first in 2013. The consistency evaluation of oral solid preparations will be carried out first; and oral solid preparations will be fully implemented in 2014. Comparing research and evaluation of generic drugs and reference preparations; 2015 will complete the task of evaluating the consistency of solid oral preparations in the Essential Drug List; from 2015 to 2020, the quality consistency assessment of injections and other dosage forms will be carried out.

In respect of the regulation of generic drugs, the “Programme” stated that in the future, a database of corporate prescriptions, processes and dissolution curves will be established through consistency assessment, and post-market surveillance of pharmaceuticals will be strengthened in accordance with the consistency assessment data reported by companies, such as prescriptions, processes and dissolution curves. .

The Deputy Director of Development of Pharmaceutical Markets (RDPAC) of the China Association of Enterprises with Foreign Investment in Medicine (RDPAC) said that Japan introduced the Drug Quality Reassessment Project in 1998 to improve the inherent quality of the listed oral solid preparations. An important means is a comprehensive and rigorous in vitro dissolution test. "This method is scientific and objective, and it is not easy to 'fake' and it can reflect the inherent quality of the product."

Large enterprises benefit from the huge market space for generic drugs. According to statistics, more than 100 drug patents expire each year from 2012 to 2015 alone. "The start of the quality consistency evaluation of generic drugs will either eliminate a batch of products or pharmaceutical companies and continue to differentiate the generic pharmaceutical industry. Some generic pharmaceutical companies will surely go out of business." Yesterday, a broker who declined to be named Pharmaceutical analysts said that some large companies such as Hengrui Medicine will benefit from it.

Some industry experts have extrapolated that more than 500 generic drugs will be evaluated in the first phase. “Consistency evaluation will involve whether the current production process and level of the pharmaceutical company can meet the requirements. If it does not meet the requirements, it may face transformation and technology upgrading, so this is a huge project.” The analyst said.

“For those small pharmaceutical companies that have not followed the advancement of technological upgrading, if the new rules and regulations are tightened after the final programmatic document is issued, it is bound to encounter capital and technical “trouble.” So, after the real deadline comes, It is time for the industry to reshuffle.” The above analysts said that for pharmaceutical companies, to meet the national requirements for “conformity between generic drugs and generic drugs,” they need to invest a great deal of energy. At the same time, this Major projects also need supporting pricing and bidding policies to assist companies in quality upgrades.