Medical network on December 21 - review 2016 pharmaceutical manufacturing industry, comes at a time when the country "much starker choices-and graver consequences-in" the year of release planning, health care, relevant policy documents have been released for examination and approval of drug approval system, is the transformation and upgrading, quality, and the efficiency of a year. From the policy issued to perform a certain time lag, in 2016 and could not immediately reflect the enterprise to deal with the results of policy, so "the pharmaceutical industry stable double-digit growth in the third quarter," 2016 years ago this data does not reflect changes under the undercurrent of industry change.
And all issued policy, all point to one thing - the pharmaceutical industry must be developed compliance. For used to savage growth of domestic enterprises, how to seek the possibility of development in more and compliance s, is the starting point of a competitive advantage.
This article summarized the pharmaceutical industry the compliance of the five links, refined focal point respectively, and the future trends are bold prediction.
1, research and development innovation
【 key words 】 new classification, clinical inspection, chemical drug registration priority review for approval
Clinical check list in 2016, all 1622 released "722" to accept the number of drug clinical trial data verification has not been completed, the CFDA has announced three new drug clinical trial data inspection checklist, all drug registration application involved in drug clinical trials need to be self checking checking gradually become regular item, also basic perfect process. Especially the CFDA audit inspection center (CFDI) food and drug administration announced eight drug clinical trial data on-site verification plan announcement, which drugs may be approved from are spies.
Prediction: as companies filing registration is more and more compliance, the clinical data of 2017 is expected to withdraw comprehensive verification of quantity will not be as high as 722 batches ", enter the site verification plan announcement of the possibility of product approved will soar.
Chemical register new classification Chemical drug registration new classification for advice since 2015, 2016 issued a formal) filings and form a complete set of requirements. Due to the chemical medicine register new classification of "consistency evaluation must be completed for generic drugs, chemical medicine, 2016 registered declare" cliff type "drop. Only one kind of new medicine affected by the new registration rules is limited, the number in line with 2015 registered to accept order, generic declaration fell into the double digits.
Prediction: chemical medicine in existing register new segment reporting data, on the basis of comprehensive introduction of CTD format will be closer to the internationalization. Or fully draw lessons from the FDA in 2017 system of NDA, ANDA.
Priority review approval in 2016, released by the CDE to priority review of drugs of the public has accumulated 12 group, first copy, listed abroad synchronous application in domestic market of generic drugs, major diseases, such as antitumor and HCV drugs), such as children's drugs were incorporated into the priority review.
On October 10, 2016 to now, CDE priority review published in 150 accept order priority review list. Import enterprises get priority review preparation number have bristol-myers squibb (ShuRuiWei o Asunaprevir capsule, DaclatasvirDihydrochloride slice, soft capsule, dara he wei hydrochloride), bayer (rui GeFei, toluene sulfonic acid sorafenib pills, Leo west gung and injected with human recombinant coagulation factor Ⅷ), abbvie (Chablis wei, obi, pills and Ada wood single injection) and yeung sum (reed his piece, west meirui wei capsule and zlatan ibrahimovic for capsule).
Domestic enterprises is hengrui (right beauty holds the mi hydrochloride nasal spray, gadolinium cloth alcohol injection, sulfonated liver decyl sodium injection, palmer made ossification alcohol injection and injection of mooring Finn net card) by injection of acetic acid, qilu the treatment (slice, cloth Lin Zuo amine eye drops, and chlorine for spilt tobramycin eye drops and tacrolimus eye drops), zhengda sunny (budesonide f ROM powder inhaler mott \ capsule type, California rick acetate injection and gadolinium acid disodium injection) and broad day morning (bei the other eye drops, qu fu other eye drops and v consult eye drops).
Prediction: priority review approval system guides the direction of enterprise innovation, expected to antitumor medicine, pediatric medicine and the first copy is still 2017 firms declare priority review.
2, the production quality
【 key words 】 consistency evaluation, flight inspection, process inspection, environmental protection system of production, marketing authorisation
Consistency evaluation as quality improvement of the most important policy consistency evaluation of main frame file has been published, the patch file is still in release, enterprise is the startup consistency evaluation of the project has been started. Released from the consistency of the evaluation reference preparations to observe the participation of enterprises, the 289 needs to be completed in 2018 the consistency in the evaluation of product, there is still a product no enterprises for the record.
Forecast: 2017 will BE the key to the sprint consistency evaluation, is expected to have a mass product declaration BE put on record, the inspection BE clinical agencies will support the enterprise needs time. Consistency evaluation also in promoting the imported drugs in production process, our country real estate of generics companies already listed in the us and Europe, countries are actively looking for import opportunities in China.
Flight to check in early 2016, the CFDA issuing annual drug inspection report for the first time for annual medical check and inspection found that the main problems are expounded, including 2015 began flying inspection. 2016 flight check is still mainly concentrated in enterprises, biochemical medicine, Chinese medicine extract and injection of biochemical medicine raw materials fly strengthening inspection, and released "about for drug production quality management standard biochemical drugs of the opinions of the appendix", increase the monitoring of raw material supply chain management.
Prediction: for larger sales scale products, biochemical medicine or Chinese medicine enterprises layout drug should be started in 2017 to evaluate projects, through quality control especially key control ensure the future of drug efficacy components.
Process check list in 2016, launched comprehensive verification, enterprises should finish inspection in October 31, 2016. On November 1, 2016 CFDA experts of production enterprises to carry out the flight check. Check found in actual production process and drug regulatory approval for the production process is not consistent, according to the counterfeit drugs. Is inconsistent with the actual production technology and production processes approved pharmaceutical producing enterprises shall be completed before June 30, 2017 in product production technology research and validation, submit supplementary application and so on related work, no other products should be completed before December 31, 2017 the work; Did not finish, should stop production.
Prediction: flight check for process verification in 2017 are expected to increase, with the production approval but actually don't production is expected to be through the process check list for verification to determine drug information.
Environmental protection production Of environmental problems caused by haze weather forced the pharmaceutical industry in hebei province to shut down in the last quarter of 2016 industries, new emissions of the enterprise is more and more stringent environmental regulations.
Prediction: in 2017, more and more active pharmaceutical ingredients companies will actively developing green chemistry, response to the layout of the pharmaceutical industry development planning guide has a characteristic of active pharmaceutical ingredients.
Authorisation system As early as 2013, released the CFDA regarding the implementation of the new revised drug production quality management standard in the process of drug technology transfer matters related to notice (the food drug safety note [2013] 38), in 2016, is the final years of the policy. In order to reduce unnecessary production equipment investment, let go of new drugs and won the award for the consistency evaluation of drug processing, marketing authorisation system came into being in 2016, mainly for 10 pilot provinces, but the details of implementation of related guidance document has not been announced.
Forecast: 2017 people for authorisation system is expected to further promote the small and medium-sized marriage of research and development institutions and production enterprises.
3, the health
【 key words 】 "4 + 7" comprehensive pilot provinces, 200 pilot cities, GPO mode, sanming alliance
Complete coverage of 2016 county-level hospitals, comprehensive reform pilot provinces city hospital increased from the original four provinces to 11 provinces, reform pilot city expanded to 200 cities. Control drug prices and drug proportion still is the main melody of health reform in 2016, was one of the auxiliary medicine catalogue, drug monitoring management policy is to control the medicine proportion.
D couplet of bargaining model is expected to solve drug zero rate for problems brought about by the hospital income. 2016, however, not all the health city launched the bargaining. Provincial platform into the market price is determined after each couplet of medical health city through negotiation purchasing medicine is expected to be legalized, 2017 with the health city bargaining plan, the enterprise will face more bargaining project execution at the same time.
In 2016, the new model of concern is the Shanghai and shenzhen hospital medicine (GPO) model of group purchase, and pharmaceutical joint negotiations in sanming purchasing alliance mode, is expected in 2017 will still have the health city to join the two kinds of patterns.
4, payment system
【 key words 】 the unity, medical insurance directory, cross to health care, health care payment price adjustment
2016 people club department is very busy, "two unity" mission expected to be delayed until 2017, only hunan announced the integration of "two unity" directory. Sensitive information discovery, hunan "two unity" supplemented directory mainly on medicare catalog supplement new agricultural varieties and dosage forms, and adjust the medical insurance directory of the original to the demarcate of the drug to pay limits, a large number of drugs were canceled pay restrictions.
The second half of the year, people club department issued medical insurance directory adjustment scheme, medicare pays the price payment standard solution, even also has health care implementation may across.
Prediction: for enterprises, the payment system of the opportunities and challenges coexist. Generic chemical medicine and bidding price to pay for health care, means that the upcoming payment standard is still good to have clinical value and exclusive products. 2017 will be "confirmed", "health insurance directory adjustment", "price of health care payment", "health care" policy, the official launch ZhiHangNian, provincial "two unity" project directory and paid price is likely to be concentrated in 2017.
5, commercial channels
【 key words 】 two votes to increase and CSO + camp mode, circulation field
Since April 2016 finance department released to add "camp" full implementation of the decision, and promulgated by the state council reform pilot cities nationwide pilot "two votes" since the announcement, marketing classes almost every day since the media in the brush "two votes + camp to increase" in the face of the mode of training, marketing outsourcing (CSO) mode is recommended for the mainstream.
It is worth noting that the "two votes to add" + camp driven to build the Chinese characteristics of CSO models were mostly set cost. And released in May 2016 CFDA medicine circulation field illegal conduct on the regulation of announcement no. 94 (2016), including regulation of votes go demands. In addition, the cost of drug sales is limited, CSO mode can't afford to support base to the bidding price spread need ticket section.
At the end of 2016 most of the provinces has not yet issued "two votes" management regulations, "two votes" is expected to officially executed in 2017, for the industry reshuffle effect will be in the second half of 2017.
In 2016, mainly in foreign sales outsourcing. Foreign companies for the domestic distribution rights, or to a large circulation enterprises, or to the compliance and clinical promotion network mature CSO company (such as million and Kang Zhe). Sales personnel outsourcing, resulting in a large number of foreign companies marketing and market was laid. Expect the good drug promotion trained foreign companies remain competitive, marketing personnel, was eliminated by spreading is only kims marketing don't understand the promotion of the product marketing personnel.
Conclusion the < < <
Many policy beginning in 2015 has been officially released in 2016, before the forecast will accelerate industry reshuffle of secondary bargaining, 2010 version of the GMP upgrade did not actually achieve the objectives of the policy is the default. In 2016, some new policies such as "two votes" also fails to perform in 2016.
Enterprises in 2017 is still the biggest challenges for market access, consistency evaluation will become the medicine access to generic drugs production enterprise, facing process verification, the production risks of environmental problem.
As more and more become the reform pilot city, the enterprise the past to "save" the layout of the mind will return to "city" as the unit of trade-offs, couplet of 2017 is about to perform a variety of medical bargaining and medicare payment standard project will impact to the product price. |
