News Center

Opportunities and Challenges of "the belt and road initiative" Emerging Pharmaceutical Market

As we all know, China has become the world's second largest biomedical market. However, in recent years, under the influence of a series of policies such as consistency evaluation and volume procurement, the domestic pharmaceutical market environment has changed dramatically, and international development has become an important starting point to promote the structural adjustment of China's pharmaceutical industry and the transformation and upgrading of pharmaceutical enterprises. In the process of internationalization, on the one hand, the growth rate of the pharmaceutical market in developed countries and regions such as Europe and the United States has slowed down, the requirements of technical regulations are strict, and it is more difficult to enter; on the other hand, the potential of emerging markets is huge. According to statistics, 80% of the future growth in drug sales will come from emerging markets. By 2022, emerging markets will account for the global drug market.

11-04

GMP certification canceled the latest news announced

In the future, supervision and inspection records will become proof of compliance with GMP requirements, because the law requires the disclosure of all regulatory results, and each enterprise, the result of each inspection, is proof of GMP compliance. Recently, the industry authorities in an interview with Cyber Blue said: the cancellation of GMP/GSP certification is not new, as early as a few years ago began. In the future, supervision and inspection records will become proof of compliance with GMP requirements, because the law requires the disclosure of all regulatory results, and each enterprise, the result of each inspection, is proof of GMP compliance.

11-01

Well-known pharmaceutical companies have made efforts to high-end generic drugs, new drugs, high gross profit will continue.

A movie "I am not a drug god" adapted from the real purchasing of life-saving drugs brought the word "generic drugs" into people's vision. The so-called generic drugs, that is, after the end of the patent protection period of patented drugs, do not have the patent of the pharmaceutical companies imitation of alternative drugs. Generic drugs have the same therapeutic effect as the original drugs. At the same time, due to the relatively low price, generic drugs have become the choice for patients to reduce the burden of medicine. On October 9, the National Health Commission issued the "Notice on Printing and Distributing the First Batch of Encourage Imitation of Drugs". The catalog includes 33 drugs including anti-cancer drugs, rare disease drugs and immune system treatment drugs. Almost at the same time, drugs

10-23

State Food and Drug Administration: medical device coding date, variety officially released.

The official draft was released on October 15 (draft for comments on September 17), the implementation date and some contents were revised, and the notice of medical device coding was officially issued. Attached at the end of the article is a catalogue of 64 varieties in the official version. On October 15, the official website of the State Food and Drug Administration issued a notice on matters related to the implementation of the first batch of unique identification of medical devices. Prior to this, the State Food and Drug Administration issued a draft for soliciting opinions on the requirement. After revision, the confirmed "Notice" clearly stipulated the scope, schedule and work requirements of the first batch of medical device unique identification.

10-17

A new round of price war! "4 7" Expanding the Quotation Strategy of Pharmaceutical Enterprises

On September 1, Shanghai Sunshine Pharmaceutical Network released the "Document on Centralized Procurement of Drugs in Alliance Regions". The document pointed out that on the basis of the results of centralized procurement implemented in "47" cities and provinces that have followed up and implemented, the state organized relevant regions to form alliances and carry out centralized procurement of drugs in cross-regional alliances in accordance with the law. This purchase is "47" winning 25 varieties, with a purchase volume of 4.74 billion (pieces/bags/branches). According to incomplete statistics, under the agreed purchase volume base in the first year, according to the "47" bid-winning purchase price, the purchase amount of 25 bid-winning varieties is about 6.96 billion yuan. The variety with the largest purchase amount is Right Meto.

09-17

New "Drug Administration Law" Released Experts Call for Correct Interpretation

"A movie changed China's Drug Administration Law" "illegal purchase of drugs from abroad can be exempted from punishment" "GMP, GSP certification after the cancellation of the easier to build a pharmaceutical factory" ...... The newly revised Drug Administration Law (hereinafter referred to as the new law) after the adoption of the review, for a time, the interpretation of the new law is overwhelming. On September 5, the expert team of the National Drug Policy and Pharmaceutical Industry Economic Research Center (NDPE) of China Pharmaceutical University, which has been deeply involved in the revision of the law since 2013, said in an exclusive interview with a reporter from Science and Technology Daily that the new law should be interpreted reasonably to avoid public misunderstanding. Penalties for illegal purchase of drugs abroad

09-10