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Major national policy inventory for the pharmaceutical industry in 2014

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1. The State Administration of the State strengthens the supervision of important extracts and extracts


In August, the State Food and Drug Administration issued a notice requesting the strengthening of Chinese medicine extraction and extract supervision. The notice is clear that since January 1, 2016, Chinese patent medicine manufacturers are not allowed to purchase unregistered Chinese medicine extracts for production. Where a proprietary Chinese medicine manufacturer uses the prepared Chinese medicine extract for production, it shall conduct quality assessment and supplier audit of the Chinese medicine extract production enterprise in accordance with the GMP requirements of the drug. The Chinese herbal extracts will no longer be managed according to the approval number, except for the active ingredients and effective parts of the Chinese medicines approved by the new drugs. Chinese patent medicine production enterprises fail to produce, purchase and use traditional Chinese medicine extracts instead of traditional Chinese medicine decoction pieces according to the drug standards.


2. The formulation and implementation of the Chinese medicine standard system needs to be adapted to local conditions


In recent years, Chinese medicine has frequently fallen into the quality door. In response to this phenomenon, the relevant state departments have adopted a series of programs to deal with it, but the fundamental problem is the industry standard. In the process of quality supervision of traditional Chinese medicine, the implementation standards cannot be across the board. It should be determined according to the actual situation. The government should also consider the balance in the process of implementing standards. On the one hand, it regulates corporate behavior and industry rules, on the other hand, it guides enterprise development and industry. progress.


3. The 2015 edition of the Chinese Pharmacopoeia was entered into the later stage.

In October, Zhang Wei, secretary-general of the National Pharmacopoeia Commission, said at the “Injection Industry Conference 2014” that the preparation of the 2015 edition of the Chinese Pharmacopoeia (hereinafter referred to as the 2015 edition of the Pharmacopoeia) has entered a later stage. In accordance with the objectives set out in the preparation outline and the principle of “admission to quality”, the work has progressed steadily. From the overall situation, the safety, effectiveness and quality control level of the 2015 edition of the Pharmacopoeia have been improved, and the total number of “chemical drugs, biological drugs meet or close to international standards, and Chinese medicines lead international standards” has been basically realized. aims.


4. The Chinese medicine law is expected to introduce the government to promote the development of traditional Chinese medicine for 30 years.


For the first national law regulating Chinese medicine and Chinese medicine, the legislative work of the Chinese Medicine Law has been receiving much attention.


On November 5th, it was learned through the National Health and Family Planning Committee's "Regulations on the Construction of Rule of Law and Law Enforcement Supervision of Health and Family Planning" that the National Health and Family Planning Commission is accelerating the legislative work of the "Chinese Medicine Law". (Draft for Comment) has completed the public consultation, and the relevant departments of the Legislative Affairs Office of the State Council are summarizing the solicitation of opinions and further revising the draft based on the opinions. But when it came out, there is currently no exact timetable for the official.


5. The impact of the central bank's interest rate cut on the Chinese herbal medicine market

The People's Bank of China decided to reduce the benchmark interest rates for loans and deposits of financial institutions (6.2426, -0.0004, -0.01%) from November 22, 2014. The one-year lending benchmark interest rate of financial institutions was lowered by 0.4 percentage points to 5.6%; the one-year deposit benchmark interest rate was lowered by 0.25 percentage points to 2.75%, and combined with the promotion of interest rate marketization reform, the upper limit of the floating range of deposit interest rates of financial institutions was determined by the deposit benchmark. The 1.1 times interest rate is adjusted to 1.2 times; the benchmark interest rates of other grades of loans and deposits are adjusted accordingly, and the benchmark interest rate term is appropriately deprecated. The interest rate cut will have the expected recovery effect on the current weak drug market demand. The interest rate cut is the overall market situation, and it is the advance signal that the drug market will enter the end of the bear market or will gradually end.


6. Drug government pricing will be canceled and still subject to medical insurance and bidding restrictions

The implementation of drug government pricing for nearly 20 years, or will end on New Year's Day in 2015. Although the government intends to guide the actual transaction price of drugs to be formed by market competition, after the drug government price is cancelled, the drug price will still be subject to medical insurance control fees and bidding procurement. At the same time, medical institutions will join as price negotiators.


7. Chinese herbal medicines are ups and downs, and there is a call for a reserve system in agriculture.

In the face of the trend of moody Chinese herbal medicines, some Chinese patented companies have chosen to develop their own planting bases in order to prevent risks. This can alleviate the cost pressure when the price of Chinese herbal medicines soars, but once the price of Chinese herbal medicines plummets, the planting base becomes a burden for pharmaceutical companies. A number of executives of listed Chinese patented companies have called for the government to take the lead in establishing a national and local Chinese herbal medicines reserve system to store and store large quantities of Chinese herbal medicines in order to control the surge in prices of Chinese herbal medicines and stabilize the supply of medicines.