The exit of the combination of imitation innovation is increasingly attracted to the industry's attention，Recently, Huahai and Hengrui have successfully obtained drug registration in the United States to let domestic companies see the hope of exports。

 

  Encouraged by consistency evaluation policy，More and more domestic enterprises seeking the possibility of simulating drugs at home and abroad。

 

  I think，At present, it should focus on the following three aspects of soft power improvement。

 

  Shortcut: Two main modes

 

  Encouragement of various policies in China，and the valuation of foreign projects is more reasonable than domestic projects，Various factors have promoted the development of Chinese pharmaceutical companies overseas，Overseas investment mergers and acquisitions projects are also increasing。

 

  United States、EU、The essential condition for registered drug registration in Japan and other countries is that there are local agents or agents，Therefore, Chinese pharmaceutical companies must simultaneously listed patents at home and abroad to expire with high -end generic drugs，At present, there are two main modes。

 

  A model is to invest in the establishment of a pharmaceutical research and development company or a pharmaceutical company in foreign countries，is in the United States、EU stake sports betting appand My stake betting appother investment set up a wholly -owned controlling subsidiary engaged in drug research and development。When the test results of the laboratory can support the next step to amplify the production，A large batch of trials in the middle test、Registration batch and verification batch production transfer to pass through the United States、Domestic factory of EU GMP，So as to produce the US or European Pharmacopoeia、Technical Guide and Drugs of my country Regulations。Chinese enterprises are registered and declared in accordance with the ICH CTD format file templates in accordance with the above processes，At the same time, the electronic declaration requirements of registering the country at the same time are submitted in ECTD format，to achieve domestic and international simultaneous registration。

 

  Another model is to cooperate with foreign companies to set up a joint venture or holding foreign companies。Domestic pharmaceutical companies can choose to target national brand enterprises or third -party institutions as cooperative objects，Common cooperation with a joint venture company or holding the target company。Local companies are relatively familiar with regulations and processes of local drug access，will help my country's pharmaceutical companies open the local drug market。

 

  Essential conditions: foreign GMP, familiar with CTD

 

  Before the registration application for drugs required by the United States and the European Union is approved，Its production address needs to be pre -certified by GMP through the production management specifications of international official institutions。Foreign GMP qualifications have become Chinese pharmaceutical companies exported to Europe and the United States & ldquo;。At present, many companies in my country have passed the United States、EU、WHO or Japan's GMP authentication，This also shows that the hardware conditions of many manufacturers in my country meet the GMP requirements of international official institutions。

 

  but，Recently, the US FDA and EMA EMA and other institutions have issued a lot of & ldquo; data integrity insufficient data integrity & rdquo;stake online sports betting，Chinese pharmaceutical stake sports betting appproduction enterprises for drug production、Data generation and record process specifications insufficient understanding。

 

  CTD aspect，ICH CTD is mainly divided into five major sections，Except module 1 (regional administrative management information)，The remaining four modules are CTD format files，is the writing format of the registered document of the international pass。Module 2 is the CTD file review part，is a module 3 (drug quality module)、Module 4 (Non -Clinical Research Module)、Module 5 (clinical research module) review。CTD files basically cover a whole process management from research and development to production，CTD format is not just a simple registration application file format，Its research and development of drugs、Production and clinical aspects have high technical requirements and more scientific content design requirements。

 

  my country's "Requirements for the Application Information of the CTD Format Format Format of Chemistry" was officially released on September 25, 2010，but not the module 4 and module 5 in the international ICH CTD file format。The "Chemical Pharmaceutical Data CTD Format Electronic Document Standard (Trial)" published on July 12, 2011 was uniformly specified。May 4, 2016 "The Requirements for the Requirement of the New Classification Classification Reporting Information (Trial)，It clearly specifies that the pharmaceutical materials of the new registered and classified products of chemical drugs are declared in CTD format，This version officially adds the relevant part of Module 4 and Module 5。

 

  So far，Chemical CTD format application information writing requirements have been carried out in my country for more than five years，Drug research and development enterprises and application units also gradually become familiar with the CTD format declaration，This helps Chinese companies absorb international advanced experience，Optimize your own drug registration work process，Help enterprises in line with international standards。

 

  Compared with the supporting guidance principles provided by ICH CTD，my country's CDE's technical guide My stake betting appis Stake Sports Bettingreleased slowly。For example，Quality、safety and effective，The concept of QBD (quality derived from design) in the CTD format file，But my country has not released targeted guidance principles。To fill the blank of the guidance file，August 2016 CDE shared WHO、ICH (International Coordination Association of International Pharmaceutical Registration Technology Requirements)、FDA, EMA and other various technical guides。

 

  In addition，CDE also released the CTD module 4 new drug non -clinical research evaluation.。M3 guidance principle is to accelerate the process of entering clinical trials through non -clinical research of new drugs，Improve the efficiency of new drug research and development，Guaranteed potential (safety、Effective) New drugs enter the clinical trial as soon as possible，At the same time，According to the safety risk characteristics of the new drug，Pay test items、Test cycle, etc., perform risk control to shorten the time limit for non -clinical research。In particular, the M3 guidance principle encourages drug R & D enterprises to consider non -clinical trial content in accordance with the purpose of clinical development，However, most Chinese companies still use traditional clinical trials，Not yet established an exploration clinical trial classification。

 

  QBD Application: The gap is not small, it should be introduced as soon as possible

 

  The global pharmaceutical industry has entered & ldquo; patent cliff & rdquo;，A large number of brand medicines are losing the exclusive patent right。Choose best -selling medicine for patent overdue、Improve production efficiency and product quality、Reducing production costs and productives is a problem that my country's pharmaceutical companies focus on。Quality comes from the process control and endpoint control of the design system (QBD) guide、Pharmaceutical quality control concept of comprehensive system，It is the international research and development idea that Chinese enterprises are exported to Europe and the United States。

 

  The entire drug research and development of the entire drug with the traditional quality management system stake betting app(QBT) My stake betting appmainly depends on experience，and study usually changes only one factor variables each time，QBD is based on the material attributes and process parameters related to preparation products、Understanding of related mechanisms，Multi -dimensional experiments to comprehensively understand products and processes。

 

  my country's current QBD research is still in the early exploration stage，Theoretical research and industrial applications still have a distance，For example, my country's consistency evaluation research should actively introduce QBD management ideas。This requires the experience of the pharmaceutical industry for QBD applications、Data to share and discuss，CFDA should also introduce the QBD guide as soon as possible and promote learning，This will be conducive to the internationalization of domestic enterprises，So in the face of global competition。