-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On October 23, the State Administration of Food and Drug Administration issued a draft of the <> Amendment and the Measures for the Administration of Drug Registration (Amendment). The former is the highest law in China's drug regulation, while the latter is the most important regulation in the field of drug registration. This revision is an important measure to implement the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices (the "Innovation Opinions").five bright spots
This revision of the drug management law has three main bright spots:
First, the full implementation of the drug market licensing system, clear related obligations and legal responsibilities. The move, which is in keeping with the drug regulatory model in Europe, the United States and Japan, will effectively boost the enthusiasm of non-pharmaceutical research institutions for new drug research and development.
, implement the requirements of the reform of the administrative examination and approval system and simplify or cancel some administrative examination and approval procedures. Cancel the administrative approval of GCP, GMP and GSP certification, change the clinical trial institution from certification to filing, change the approval of drug clinical trial from express license to implied license, implement record management of bioequality test, and review and approval of raw materials, pharmaceutical accessories and packaging materials without separate listing license, and review and approval with the corresponding preparation listing license.
, in order to ensure that the "Innovation Opinion" related measures as soon as possible to implement, the drug management law is only a partial revision. The State Administration of Food and Drug Administration said it aims to speed up the comprehensive revision work by the end of the year, including patent links, patent period compensation and other exploration and pilot work.
the management methods of drug registration in China are mainly two bright spots:
First, the classification of drug registration is facing changes, with innovation and effectiveness as the core principles of classification. Chemical and biological drugs are divided into three categories: innovative drugs, improved new drugs and generic drugs. Chinese medicine and natural medicine are divided into four categories: innovative medicine, improved new medicine, similar medicine and ancient classic prescription.
, clear working time limit, some links of new drug time limit is better than non-new drugs. The working period of the drug market application review process is 100 working days for new drugs and 120 working days for generics, biosimilars and traditional drugs.Release good more than
industry insiders believe that this revision is mainly aimed at domestic innovative drug research and development end incentives, limited clinical trial capacity, clinical and market declaration approval time is too long and other aspects, for innovative drugs to provide a lot of practical convenience and benefits.
From another perspective, with the gradual introduction of classification management, domestic standards for innovative drugs will increase, Me-Too or even Me-Worse drugs, which used to be less innovative, will be hit, and companies that are truly capable of achieving global innovation levels will focus on the policy dividend.
Xu Jiaxuan, a pharmaceutical researcher at Henyep Securities, believes that with the policy environment of innovative drugs gradually in line with those of Europe and the United States, the future valuation system of innovative drugs is expected to change from PEG indicators (price-earnings ratio to earnings growth ratio) to Pipeline (variety echelons), and enterprises with large varieties of pipeline will receive valuation premiums. (China Securities News)