Pharmaceutical Network December 1st News 2015，The new version of the Pharmacopoeia starts today，This is the 10th edition of Pharmacopoeia since the founding of New China，What are the special features of this version of the new pharmacopoeia，What changes will it bring to the industry?

 

 

1, variety increase

 

 

The total number of varieties of the new version of the pharmacopoeia reached 5608，1082 new varieties than the 2010 version of Pharmacopoeia。

 

 

New version of Pharmacopoeia increases by 105%in medicinal accessories，increased from 132 species to 270 species。

 

 

2, focus on the role of four aspects:

 

 

Maintain public health，Affairs of guaranteeing the safety and effectiveness of the medication & rdquo;

 

 

The function of leading industrial structure adjustment and product quality upgrades & rdquo;

 

 

The role of a booster & rdquo;

 

 

Chinese Pharmaceuticals Realizing Quality Hard Promotion、The role of the Rainbow Bridge & RDQUO;。

 

 

3, the quality requirements are stricter

 

 

Traditional Chinese Medicine: The limit standard of sulfur dioxide residue in Chinese medicinal materials and slices is formulated，stake sports betting appPromote stake sports betting appthe establishment and improve heavy metals and harmful elements、Yellow Gloves、The detection limit standard for substances such as pesticide residues; strengthen the control of toxic and harmful substances for heavy metals and Chinese medicinal materials。

 

 

Chemical drugs: Research on the qualitative and quantitative measurement method of material enhancement，Difference control of known impurities and unknown impurities，Optimize the measurement method of antibiotics polymer，Set reasonable control limit，Overall to further improve the scientific and rationality of relevant material projects。

 

 

Biological Products: Increase Requirements for General General Theory，Strict quality control requirements for strict biological products，To ensure the safety effectiveness of the product，At the same time, add & ldquo; biological products production and auxiliary materials quality control universal technical requirements & rdquo;，Strengthen the source control，Maximum reduction of safety risks, etc.。

 

 

4, the standard of drinking pieces has increased significantly

 

 

The new version of the pharmacopoeia increases the means of safety testing for Chinese medicine，In particular, the detection of heavy metals has reached the international advanced level;，A new method was used，Have better specificity and sensitivity，Can detect 229 kinds of pesticides residue。Take commonly used drinks as an example，The new version of Pharmacopoeia has added sulfur testing of yam and Pueraria; pearls and seaweed have increased detection items such as heavy metals;。

 

 

2015 version of "Chinese Pharmacopoeia" on the basis of the Pharmacopoeia，Control requirements for strengthening drug safety and effectiveness，Fully drawn from international advanced quality control technology and experience，Overall improvement of the standard level of the pharmacopoeia，It will be promoting the improvement of drug quality in my country、Accelerate the Stake Sports Bettingstake online sports bettingtechnology progress of enterprises and product upgrades、Promote the adjustment of my country's pharmaceutical industry structure、Enhance the authority and international influence of "Chinese Pharmacopoeia"。

 

 

5, the quality of the auxiliary materials must be improved

 

 

Zhang Wei, Secretary -General of the National Pharmacy Commission, said，Although the quality and standard level of the auxiliary materials are still different，Follow the development trend of the international pharmacopoeia，Use new technology、New methods to ensure drug safety and effective。

 

 

The impact on the industry

 

 

1, push the cost of high pharmaceutical companies?

 

 

The new version of the Pharmacopoeia puts forward higher requirements for drinking slices，At present, Chinese medicine companies are more and more stringent compared to before。The monitoring of the raw materials of the previous medicinal materials may be a passing field，But now it's really played。According to those familiar with the medicinal material market, I said，Currently, medicinal materials dealers are frequently encountered returns，Sulfur -free medicinal materials are becoming a market tight product，Everyone is looking for sulfur -free goods。Sulfur -free goods are now rising in price。The difference between the price is two or three dollars，Some price differences have double differences。Prevention，After the execution of the new version of the Pharmacopoeia，Sulfur -free medicinal materials will further open the gap with sulfur -containing medicinal materials。The cost of pharmaceutical companies will rise further。

 

 

2, will traditional Chinese medicine supply short -term supply?

 

 

Deeper concern for pharmaceutical companies is that once the pharmacopoeia is executed，According to the current status of the planting of Chinese medicinal materials，Are there any qualified medicinal supplies for pharmaceutical companies?

 

 

The new version of the pharmacopoeia is in Chinese medicinal materials、The quality control of Chinese stake betting appstake betting appmedicine drinks, especially in the residue of sulfur dioxide、Pesticide residue、Heavy metals and harmful elements，Yellow Gloves、Pigment、Microorganisms、Monitoring of endogenous harmful substances，Standard has a significant increase compared to the 2010 version，Especially farming residue、Control of heavy metals and harmful elements，Achieve or exceed the advanced national standards such as Britain and the United States。

 

 

Recently, the new pharmaceutical code will be executed，Once the new version of the Pharmacopoeia is executed，Whether it will appear in stages on the one hand, the backlog of the drug farmers and the medicinal material market，On the other hand, drinking processing enterprise、Chinese medicine manufacturers look for qualified medicinal materials and tablets、The hospital has no qualified drinks available? This should cause government regulatory authorities、Operator、Planting farmers、Pharmaceutical companies pay attention to and prevent early。

 

 

Pharmaceutical companies are facing good medicinal materials and difficult to find，Pharmaceutical dealers may face the backlog of supply because the product is not closed，A battle of fate about the Chinese medicine industry is about to start。

 

 

3, closely related to the medical insurance directory

 

 

According to an introduction，"China Pharmacopoeia" 2015 edition of the collection of new varieties mainly considers the needs of clinical drugs，Especially considering the varieties collected by the pharmacopoeia covered the drug varieties listed in basic drugs and medical insurance directory，At the same time, it also provides a basis for the selection of basic drugs and medical insurance varieties in the future。For varieties that are not collected by the pharmacopoeia，There are many reasons。

 

 

For example, there are certain efficacy or safety problems in this variety; there are similar varieties with better or more safety.stake betting appstake online sports betting，Or use internationally controversial animal medicinal materials and some human -source medicinal materials。If in Chinese medicinal materials，Zihe car that does not collect from the placenta of human beings，It is because of its possibility of potential virus and other microbial infections and ethical problems。