Breaking the barrier of "going to sea" and obtaining the "pass" of international market

[trends of pharmaceutical Station industry] in recent years, under the environment of lower tariff rate of imported drugs and favorable domestic pharmaceutical policies, the quality and efficiency of pharmaceutical foreign trade has been steadily improved, and the structure of foreign trade has been continuously optimized Many pharmaceutical enterprises have begun to try to break the "go to sea" barrier, and realize the drug going out while exploring overseas markets In March 2019, Shandong Yuxin Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Luoxin pharmaceutical, obtained the double certification of EU GMP certificate for solid preparations (Germany) and PIC / s GMP certificate for freeze-drying & solid preparations (Ukraine) Among them, GMP is the production quality management standard, which is the need for pharmaceutical enterprises to connect with the international standards, and is an effective measure to prevent drug quality risks and safety accidents The certification process is longer, less than one year, more than two or three years The so-called PIC / S is the abbreviation of the International Drug Certification cooperation organization PIC / s GMP is the global strict GMP standard so far Therefore, the implementation of PIC / s GMP can further improve the quality of drugs and ensure the safety of drug use The success of double certification is the breakthrough of Yuxin pharmaceutical's preparation international certification, which means that its quality management level has reached the international standard It also means that the listing of Yuxin pharmaceutical's self-produced products in 28 EU Member States and more than 50 PIC / s member units has broken through GMP barriers, which is conducive to a more smooth entry into the international market As early as 2011, Xinhua pharmaceutical tablet products passed the MHRA certification of the UK drug and health products administration The certification is effective in 27 EU countries, marking that Xinhua Pharmaceutical's pharmaceutical production has reached the international level, and the pharmaceutical products have a "green pass" to the international market At present, all API products and dosage forms in production of Xinhua Pharmaceutical have passed GMP certification, 14 products have passed FDA certification, 9 products have obtained EU cos certificate, caffeine and other products have passed social responsibility audit and environmental certification of users in the United States and Europe Green leaf pharmaceutical the solid preparation of green leaf pharmaceutical has passed the GMP (Germany) certification of EU as early as November 2013 At present, the external oral preparation workshop of LVYE pharmaceutical has passed the TGA GMP inspection in Australia, the solid preparation has passed the EU GMP inspection, and the injection microsphere workshop has passed the EU GMP on-site inspection Qilu pharmaceutical has established a strict and standardized quality control organization and a perfect quality assurance system It is the first batch of GMP certified enterprises of the State Food and drug administration Among them, non sterile APIs, sterile APIs and a variety of preparations have passed the certification of drug regulatory agencies in the United States, the European Union, Australia, the United Kingdom, South Africa and other countries and regions Xinbang Pharmaceutical (June 17, Xinbang pharmaceutical) announced that its wholly-owned subsidiary, sinopeptide biochemical, recently received the "EU GMP certificate" issued by the German federal agency for drugs and medical devices, which will help to improve the comprehensive capacity of research and development, production and project management of sinopeptide biochemical, and help it further expand the international market According to the industry, the achievements of these pharmaceutical enterprises provide demonstration effects and ideas for other pharmaceutical enterprises to go to sea, but it is still not easy for domestic pharmaceutical enterprises to enter the overseas market On the one hand, both generic drugs and innovative drugs need to go through a long clinical approval cycle, and enterprises must be familiar with the European and American regulatory system On the other hand, pharmaceutical companies need to have sufficient technical support After all, even APIs that have entered the European and American markets will be banned from export because they fail to meet the standards.