Ten major events in the pharmaceutical industry in 2015

Source: Dandelion 2016-01-04 for pharmaceutical people, 2015 is a year of ups and downs, a year of joy and change, and a year full of opportunities and challenges A number of major pharmaceutical events have shocked the industry, and pharmaceutical companies ushered in 2016 in pain, depression and choice, while 2015 will leave an indelible mark in the memory of pharmaceutical people Do you agree with the ten major events in the pharmaceutical industry? 1 7.22 on July 22, the State Food and Drug Administration issued document No 117: the announcement of the State Food and Drug Administration on carrying out the self inspection and verification of drug clinical experiment data, which began to carry out the verification of drug clinical experiment data for 1622 applications for registration of drugs that have been declared for production or import The announcement was called "7.22 Massacre" by the pharmaceutical industry, which started the work of self inspection and verification of clinical trial data by the State Food and drug administration Many pharmaceutical companies have voluntarily withdrawn 709 drug registration applications, and the initial R & D costs have also been watered down 2 Tu youyou won the Nobel Prize for her invention of artemisinin On October 8, Tu Youyou, a Chinese woman pharmacist, won the Nobel Prize in physiology or medicine in 2015 and became the first Chinese to win the Nobel Prize in science of nature Tu youyou's Nobel Prize is the embodiment of TCM's great contribution to the cause of human health, and fully demonstrates the continuous improvement of China's comprehensive national strength and international influence 3 The "ginkgo leaf event" involving drugs and health products continued to ferment in May because the enterprise changed the production process of ginkgo leaf extract without authorization Since then, CFDA has organized a special treatment action for Ginkgo biloba leaves, informing the society of illegal addition and production record making of some ginkgo biloba extract and preparation enterprises This matter affects medicine and health products, and many well-known pharmaceutical enterprises are also involved in it 4 This year, the State Food and Drug Administration adheres to the three strict principles of serious inspection, serious investigation and punishment, and serious accountability, normalizes the flight inspection as an effective means of supervision Not only do they conduct flight inspection for pharmaceutical enterprises, but also drug dealers are covered This is no different from the invisible storm, because as long as problems are found, certificates may be taken back, allowing enterprises to lose their production and operation qualifications and close down At present, 132 GMP certificates have been withdrawn and nearly 60 GSP certificates have been withdrawn 5 On November 18, CFDA released the opinions on the evaluation of the quality and efficacy of generic drugs (Draft for comments) It was proposed that some generic drugs should complete the consistency evaluation before the end of 2018, and those who fail to pass the evaluation will be cancelled the approval number of drugs The introduction of this document will improve the uneven quality of China's generic drugs and the vicious competition of similar generic varieties 6 On December 21, the law on traditional Chinese medicine (Draft) to be implemented was first submitted to the 18th session of the Standing Committee of the 12th National People's Congress for deliberation As early as 1983, there was a proposal for legislation on traditional Chinese medicine It has been 32 years so far, and the legislation on traditional Chinese medicine has not been enacted yet Thirty two years later, the first Chinese Medicine Legislation finally ushered in the dawn of spring 7 It is possible to release the traditional Chinese medicine formula granules management method (Draft), which is seeking opinions It is also a hot issue in the recent Chinese medicine market to oppose the release of the traditional Chinese medicine formula granules production 8 The 2015 Pharmacopoeia, 2015 Pharmacopoeia of the people's Republic of China was officially implemented on December 1 1082 new pharmacopoeia varieties were added on the basis of the 2010 Pharmacopoeia, and the number of pharmaceutical excipients increased from 132 to 270 A total of 5608 varieties were collected 9 On May 4, the drug pricing officially released by the government and the notice on printing and distributing the opinions on promoting the drug price reform issued by the national development and Reform Commission required that the drug price set by the original government should be cancelled from June 1, 2015, in addition to narcotic drugs and class I psychotropic drugs With a history of 15 years, the policy of drug maximum retail price limit has become a history, marking an important step forward in China's medical reform 10 Pfizer, the largest Pfizer, is close to reaching an agreement with Allergan for up to $380 per share The total value of Elgin and Pfizer is more than 400 billion US dollars According to the purchase price proposed by Pfizer, the market value of the two companies is more than 340 billion US dollars The merger of the two companies will become one of the largest M & A cases in the history of medicine.