Over-the-counter drug registration approval "opens the floodgates"

Just as the promotion of drug review reform in 2015 brought "untie" to China's innovative drugs, this reform will not only further promote the development of the pharmaceutical industry and supply-side reform, but also release industrial vitality, activate the variety innovation vitality of China's over-the-counter drug industry enterprises, thus bringing more OTC products to market.On March 30, 2020, the State Administration of Market Supervision issued the Measures for the Administration of Drug Registration by Decree No. 27 of the General Administration. This is also the 2007 version of the "Drug Registration Management Measures" since the introduction of the implementation of 13 years after the update, the new version of the "Drug Registration Management Measures" will be officially implemented on July 1, 2020.In this "Drug Registration Management Measures", one of the focus of attention is to propose that over-the-counter drugs will be subject to separate registration approval. There is no doubt that this is a major breakthrough in China's drug classification management, and for over-the-counter drugs that have been subject to approval and access restrictions, this is also an "open floodgates", so that more different categories of over-the-counter drug varieties in a shorter period of time to register for the market is possible.More importantly, just as the 2015 drug review reform brought "untie" to China's innovative drugs, this reform will not only further promote the development of the pharmaceutical industry and supply-side reform, but also release industrial vitality, activate the variety innovation vitality of China's over-the-counter drug industry enterprises, thus bringing more OTC products to market.In addition, with this reform, it is also expected to further promote the reform of over-the-counter drug management in the market circulation, price and medical insurance, promote China's drug classification management with developed countries, and promote China's over-the-counter drugs to the international market.

01 listing speed upArticle 15 of the new Version of the Measures for the Administration of Drug Registration stipulates that prescription and over-the-counter drugs shall be subject to classification registration and conversion management. The Drug Review Center shall, in accordance with the characteristics of over-the-counter drugs, formulate technical guidelines and procedures for the registration of over-the-counter drugs on the market and make them available to the public. The Drug Evaluation Center develops technical requirements and procedures for the conversion of prescription and over-the-counter drugs after they are released to the public.This is also the largest change to the OTC review approval since the prescription drug and OTC product classification management measures were introduced in 2000. This means that in the future, as long as the varieties that meet the OTC declaration category can be applied for listing directly through the OTC path. CDE's development of over-the-counter drug approval standards and requirements has also made it possible for the industry to call for years to speed up the time to market over-the-counter drugs.China is considered one of the most strictly registered OTC countries in the world, and it usually takes five years for a product to be approved from application to approval, at almost the same speed as prescription drugs. The main reason for this is that there is no independent review and approval method for registered access to OTC products, but rather the same approval process and technical requirements as prescription drugs.In the 2007 edition of the Measures for the Administration of Drug Registration, if the declaration of over-the-counter drugs conforms to the relevant provisions of over-the-counter drugs, it shall be approved and managed in accordance with over-the-counter drugs; Two kinds of drugs that can be managed according to the approval and administration of over-the-counter drugs are proposed: (1) drugs that change dosage form of over-the-counter drugs as determined by the State Food and Drug Administration, but do not change the main treatment of the adaptation or function, the dose of administration and the route of administration of drugs; and (2) the use of new compound preparations consisting of the active ingredients of over-the-counter drugs determined by the State Food and Drug Administration.Despite the path to over-the-counter drug listing applications, prescription drug requirements are actually implemented at the time of review and approval, which clearly limits and slows the number and speed of over-the-counter drug listings.Wang Wei, secretary-general of the China Over-the-Counter Drug Association, said that over-the-counter drugs are long-term use, accurate efficacy, high safety, generally used for common minor diseases, over-the-counter drug innovation is mainly reflected in the new compound, new dosage form, new specifications and new tastes and other micro-innovation, so the over-the-counter drug market should be different from prescription drugs, reasonable relief of review requirements, shorten the review time is the international review of over-the-counter drugs on the market.Compared with the previous one, the Drug Registration Management Measures list four situations in which applications for over-the-counter drug listing permits can be made directly:(1) there are already the same active ingredients, adaptive disorders (or functional treatments), dosage forms, specifications of over-the-counter drugs on the market;(2) Drugs that change dosage form or specification of over-the-counter drugs as determined by the State Drug Administration, but do not change the adaptive disorder (or functional treatment), dosage and route of administration;(3) New compound preparations consisting of active ingredients of over-the-counter drugs as determined by the State Drug Administration; and(iv) other cases where over-the-counter drug listing permits are directly declared.   Wang said that the current registration management measures in the four categories of listing path is also a reference to other countries, especially Japan in this regard related requirements. Compared with the previous over-the-counter drugs in accordance with prescription drug requirements for approval, the former will be based on the registration category and variety of specific conditions reasonable relief of pharmaceutical, pharmacological and clinical review technical requirements, in the market speed, will be much higher than before.

200 billion market "open the floodgates"   In recent years, China's OTC market has developed rapidly, the market size has increased from more than 20 billion yuan in 2000 to more than 280 billion yuan in 2017. But on the other hand, subject to the strict registration method, OTC new products to market slowly, corporate enthusiasm is also greatly affected.   Globally, countries such as the United States and Japan have targeted OTC review systems and management practices. In the United States, for example, when a drug is sold under its stated certificate of adaptation for a considerable period of time and a fairly wide range, it is considered "generally considered safe and effective", after expert review can be included in the Over-the-Counter Drug Monograph and incorporated into the Federal Administration Act, if the production of over-the-counter drugs that meet the requirements of the Over-the-Counter Drug Monograph, no new drug declaration, only to the FDA filing, can be sold as over-the-counter drugs.   "China's over-the-counter drug listing review system construction has just started, is currently limited to the review process and new parties, new dosage forms, new specifications, foreign mature OTC varieties listed in China and other major categories of review technical guidelines for the formulation and implementation, and Europe, the United States and Japan and other more perfect OTC management system, should also include more innovative categories, more open review model." Wang told E-drug managers.   It is reported that at present, China Over-the-counter Drug Association is actively participating in and working with research to draft guidelines for the development of over-the-counter drugs, which will clarify the value evaluation criteria for over-the-counter drugs and several categories of market review technical requirements, focus on the differences with prescription drug reviews, to achieve accelerated and simplified core requirements, and is expected to be released within this year.   In addition, countries such as the United States and Japan have specialized OTC review departments, and from the current registration management approach, only clear process and technical guidelines, but the institutional settings have not yet made relevant provisions. At present, the first step is to optimize the technical review component, and then to promote the adjustment of institutional settings.   Obviously, with the implementation of relevant policies, China's OTC market and related enterprises will usher in important development opportunities.   Wang believes that China's over-the-counter drug varieties innovation opportunities are coming, for enterprises, the first thing to do is to refine the internal skills. On the one hand, we should improve the research ability of consumer demand and understand the change of public health demand more quickly, which is the fundamental of variety innovation. On the other hand, to scientific positioning, relying on the original brand products, extended refinement categories, to meet the needs of different patients, enhance brand thickness and breadth. Secondly, we should broaden our horizons and strengthen international cooperation. Europe, America and Japan and other developed countries have many OTC products not listed in China, Chinese enterprises can study the characteristics of these products through international cooperation model, learn from innovation experience, as soon as possible to establish their own new system of variety innovation. (
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