Hello! On the evening of July 31, 2015, the Food and Drug Administration issued the "Announcement on Soliciting Several Policy Opinions on Accelerating the Solving of the Backlog of Drug Registration Applications (2015 No. 140)" (hereinafter referred to as the "Solicitation"), requiring that August 15th is the deadline for revising materials.
Previously on July 22, the Food and Drug Administration issued the "Announcement on Carrying out Self-examination and Verification of Drug Clinical Trial Data". This document was considered by the market to have released the long-criticized drug review system. a signal of reform.
A person from the State Food and Drug Administration told Caixin.com that after Bi Jingquan took office as director of the State Food and Drug Administration, the first focus of his work was the approval of new drugs. "This is the area that has attracted the most attention and is related to the entire pharmaceutical industry and the national economy and people's livelihood. It is also an area that has been criticized for a long time and needs to be improved urgently. This is a landmark reform for China's new drug approval system."
The above-mentioned person It said that improving the standards of generic drugs is the top priority of new drug approval work. "The categories, scope, and levels of generic drugs will be reclassified, which will change the current situation of low quality, high similarity, and confusing dosage of generic drugs in China." In addition, important areas such as the new drug registration process, bioequivalence testing, and clinical research specifications will usher in major reforms.
The Food and Drug Administration speeds up the approval of new drugs
China's new drug approval system is controversial for its inefficiency and insufficient strictness, but there have been few changes for a long time. This intensive release of documents by the Food and Drug Administration has aroused widespread concern in the industry.
According to the "2014 Drug Review Report" released by the State Food and Drug Administration: In 2014, the Drug Review Center of the State Food and Drug Administration completed the technical review of 5,261 drug registration applications, which was more than The number of reviews completed in 2013 increased by 12.9%, and the backlog of pending review tasks was 18,597. The backlog of pending tasks has increased by 4,362 compared to 2013.
A source from the Food and Drug Administration said that the Drug Evaluation Center, which is responsible for the technical review of national drug registrations, currently has a staff of 115 people, including only 89 people in technical review positions. "The U.S. Drug Approval Center has about 3,600 people. There is a serious shortage of staff, which leads to low efficiency. However, the staff is limited. This cannot be found by the Food and Drug Administration just if it wants to recruit more people. In addition, the approval of new drugs involves a lot of professional knowledge, and there are not enough manpower. Resource Reserve.”
Since 2015, the State Food and Drug Administration has been increasing its recruitment. "The main purpose is to centralize review and alleviate the squeeze on drug approval. The goal is to have the same application time as Europe and the United States." The above-mentioned person said that the U.S. Food and Drug Administration generally must complete review of new drug clinical trial applications within 30 days, and China has completed the review process. The entire process takes at least five years. "We are planning to organize a special group to conduct centralized review and approval of repeatedly applied varieties. We hope to complete the centralized review and approval of some products within one year and significantly alleviate the pressure of drug backlog."
The "Solicitation for Opinions" stated, It is necessary to limit the application varieties and application time of generic drugs, and require consistency evaluation with original drugs; urge existing applicants to conduct self-examination and severely punish fraud; centrally review the backlog of varieties and speed up the approval of urgently needed clinical drugs; bioequivalence The experiment was changed from the approval system to the filing system.
In terms of process, "In the future, the review and approval of generic drugs will be concentrated to 6 years before the patent expires. The concentration of review and approval has been improved, reducing the current irregular phenomenon of grabbing generics many years in advance. In addition, children's drugs, the European Union The United States has simultaneously applied for drugs and urgently needed clinical drugs to enter the accelerated approval channel, and the specific approval standards will only be stricter and will not be relaxed to improve the effect," the above-mentioned person said.
In terms of fees, on May 27, the latest "Registration Fee Standards for Drugs and Medical Devices" and implementation details were released, and new drug registration fees increased significantly. The charges rose from the original 35,000 yuan to 624,000 yuan, 17.8 times the previous price, while the imported drugs rose from 45,000 yuan to 969,000 yuan, 21.5 times the previous price.
“The fee increase is mainly used to curb repeated filings. Compared with the U.S. fee of US$2 million, China’s new drug approval fees are not high.” The above-mentioned person said.
Improving the standards for approval of generic drugs
This "Solicit for Opinions" puts improving the standards for approval of generic drugs as the first priority.
The document states: “Generic drugs are accepted, reviewed and approved based on the principle of being consistent with the quality and efficacy of the original drugs; among the accepted generic drug registration applications, the original drugs have been approved for marketing in China, but the quality and efficacy are not consistent with the original drugs. Approval will not be granted; if the original drug has not been approved for marketing in China, it will be conditionally approved according to the original standards. The company must pass the consistency evaluation with the original drug within 3 years after the launch. If it fails, the drug approval number will be cancelled. ”
The Food and Drug Administration will also release a catalog of restricted generic varieties to reduce the number of drug applications from the source. It will improve the approval standards for the generic varieties that can be applied for and the three types of drugs that change dosage forms, acid bases, etc., and will improve drug safety, There are strict standards for equivalence and innovation, and the three categories of drugs may be reclassified into the generic category in the future. This move is intended to reduce low-quality generic drugs and increase the proportion of innovative drugs.
According to the analysis of evaluatePharma, a British pharmaceutical and biotechnology industry forecast and analysis company, in the five years from January 1, 2012 to December 31, 2016, as many as 631 patented drugs will arrive globally. In this period, the arrival of the peak of patent drug expiration means that the generic drug market will gain unprecedented opportunities.
China has always faced the controversy of being a “generic drug power” rather than a “generic drug power”. Guo Fanli, manager of the Industrial Research Department of CIC Consulting, told Caixin.com that the quality standards for generic drugs implemented in China are too low and the technical threshold required for technical review is too low, resulting in domestic pharmaceutical companies barely needing to conduct in-depth research to meet the standards. Therefore, some generic drugs in China can currently only achieve chemical equivalence, but bioequivalence, safety equivalence, and clinical equivalence are still far away.
“There is no problem with the active ingredients of generic drugs approved and marketed in China, but the active ingredients are only a small part of the drugs, and there are more excipients. The gap between domestic and foreign countries is often reflected in the excipients. In terms of quality,” Guo Fanli said.
The above-mentioned person from the Food and Drug Administration said: “U.S. regulations require that a generic drug is qualified only if it is consistent with the original drug in terms of active ingredients, route of administration, dosage form, dosage, conditions of use and bioequivalence. "However, China's current quality standards for generic drugs mainly focus on whether the active ingredients, appearance, and properties are consistent with the original drugs, while standards for consistency between generic drugs and original drugs in terms of route of administration, dosage, conditions of use, and clinical effects" are still Exploring”.
“This new drug approval adjustment will significantly improve the approval standards for generic drugs, including bioequivalence testing, clinical research specifications, in vitro dissolution curves, drug Important aspects include excipient testing and bioavailability,” said a source from the Food and Drug Administration.
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