Drug approval can lift gear acceleration

The 2015-08-28 07:44:33 | source: health | share

- our reporter Zhi-yong liu -

The xinhua news agency for the figure

August 18, the opinion about drug review of medical equipment examination and approval system reform, "the official launch. The brewing for the New Deal, medicine management can resolve China's new drug approval is now facing the big traffic jam? Can let the patient needs special urgent life-saving medicine get quick approval? Can encourage the pharmaceutical production enterprise in our country really rely on innovation drive development? This policy, and passed the drug management of deep transformation signal?

The examination and approval, at least three to five years

Too many generic low level repeated declaration

For drugs, medical apparatus and instruments for examination and approval of the review of the New Deal, in patients with hepatitis c LaoDing mixed. Because domestic interferon plus ribavirin treatment for 6 months is invalid, imports of peg-interferon plus ribavirin treatment nearly 1 years, are no better off, LaoDing has slowly fell into despair. However, a highly efficient oral antiviral drugs listed abroad, and let LaoDing "to feel the temperature of life". To inquire about, understand the long process of drug approval listed in our country, he was "head pours cold water". LaoDing said, life is like a roller coaster, introduced the New Deal did not know that it was a false, or a real hope? Experts estimate, the interferon treatment is invalid or can not accept the interferon treatment of patients with hepatitis c have millions of people.

In December 2013 to January 2013, a new drug -- SuoFei wei has been approed for sale in the United States and the European Union. Clinical trials showed that the direct antiviral drugs, hepatitis c can be cure rate from 40% to 70%, up to more than 90%. News spread to China, LaoDing and ward mates. Many doctors, however, tell them, "China's drug approval is' jam ', domestic patients using this drug to wait at least three to five years".

Not long ago, the state council information office held a press conference, wu zhen, deputy chief of the state food and drug supervision and administration bureau, said China's current backlog of drug approval request for approval has reached 21000 pieces, and every year there are 8000 ~ 10000 of a new application into center of state drug administration drug approval, and formulation of drug approval center of 120 people, can only be completed a year of 4000 ~ 5000 of them to apply for review for approval. "Mountain" application will pile up, have reached the point where they do not change no.

Each year, according to data as pharmaceutical power of the United States the new submission for examination and approval of drug approval application only around 3000 pieces. China's pharmaceutical industry development level of the gap with the United States speak for themselves, but why mass on drug applications than the United States?

Regarding this, wu revealed several other group of digits: in the backlog of drug approval for examination and approval of the application, there are eight kinds of pharmaceutical declaration enterprises more than 100, 23 kinds of drugs of the declaration enterprise is 50 ~ 99, 89 drugs of the declaration enterprise is 20 ~ 49. In 2014, the state drug administration issued two batches of excessive repeated drug catalogue, including digital equally stunning: 34 kinds of approval number of drug already on the market in China more than 500, 27 kinds of medicine between 300 ~ 500. "Too many generic low level repeated declaration, a lot of valuable review resources."

A domestic industry consultancy, published research report also pointed out that in 2014, 3.1 class of new drugs in our country, on average, the review time for 42 months, while the average American drug review time is only 304 days.

In August 2013, the production of SuoFei cloth wei gilead companies in the United States to submit the application for examination and approval of drug approval institution of China. After waiting for 16 months, finally left the supplementary data sequence of tasks, allowed to conduct clinical trials. "After finishing the clinical trials, the process of drug registration listed may be after a long wait." LaoDing now the current drug approval system to our country already very familiar with.

New concept is adjusted

In line with international standards of direction is very clear

China's pharmaceutical industry and drug regulatory enterprise, because of the influence of specific historical condition, unavoidably exist "congenitally deficient", after several adjustments, are facing and experience deeper reform.

According to professor Shao Rong pharmaceutical affairs management of China pharmaceutical university, for a long time after the founding of new China, our country has been in drug shortage status, new drug research and development ability is very weak. Initially, drug production approval to access control at the provincial level, around the local standards for the pharmaceutical production quality in succession, but there is different with the same party, tongfang different name, curative effect is not exact. With the development of economy and science and technology level, around 2002, our country cancelled the drug local standard, unified national standards, and the power of examination and approval of pharmaceutical production gradually focus to the national level.

In the process of reform, China's definition of new drugs and generic drugs are also gradual adjustment. From "not production within the territory of China medicine", to "not on sale in the territory of China medicine", and then to now "never publicly listed company in China selling drugs", the concept of the new drug has produced a qualitative change; From "imitation for national standard drugs" to "copy is in line with the original drug quality and curative effect of medicine", generic standards also got into the higher level.

Experts say, so adjust concepts and standards, convey clear encourage innovation ideas of reform. After low standard of pharmaceutical production, low level of generic pharmaceutical industry the inertia of thinking, it is the important cause of drug approval review backlog. Peking University medical health industry group vice President, founder of the institute for Yi Chongqin said: "at present, the pharmaceutical industry has a certain ability to innovate, the new reform of drug approval for examination and approval is' right ', is conducive to industrial restructuring and upgrading." Yi Chongqin tells a reporter, founder medicine research institute presented earlier this year an international cooperative innovation drug clinical trial application, waiting for the review about ranked 300th in the queue, according to the current schedule estimates, in the first half of next year is expected to enter the review stage, "hopes to mention" after the reform progress.

The reform has also proposed that to eliminate the backlog as soon as possible, to innovation medicine to carry out special review for examination and approval system, to carry out the drug marketing authorisation holder system pilot, comprehensive public review approval information, etc. To this, the China association of enterprises with foreign investment in drug research and development communication and collaboration of industry committee director ZuoYu thought, reform the unprecedented efforts, in line with international standards of direction is very clear.

LaoDing, said China's current "drug registration management method" has been, to innovation, new drug in the treatment of complicated severe diseases shall practise a system of rapid examination, he and his roommate has also reference the terms and conditions, called on relevant departments to speed up the introduction of wei SuoFei cloth. But one expert told them, "our country has not yet seen a case according to the terms and conditions to speed up the drug approval instance". LaoDing severaldays later, looking forward to, such as wei SuoFei cloth life-saving medicine examination and approval, can truly achieve lift gear acceleration.

Generic drug approval details are unknown

The third type of new drugs into a land of "unknown"

According to reporter understanding, before the reform, SuoFei cloth WeiYuanBen belongs to a "new drug"; After the reform, according to the "never publicly listed company in China selling drugs", the definition of SuoFei Mr Wei will be added to generics. And newly released documents referred to in the special review of examination and approval system, and made clear that is aimed at "new drug", this makes the SuoFei cloth wei cannot enjoy the convenience quick approval policy.

"Innovation medicine not line up with generic drugs, through the special channel to speed up the approval, is the international prevailing practice." Shao Rong tells a reporter, "but this channel should not only open to innovative medicine, some urgent clinical needs of generic assessment by the should also be included in the special approval channel."

In fact, even if the SuoFei cloth wei have been introduced into China, its high price also is many patients with unbearable, because it is in the patent protection period, in the United States sells for $1000 / piece. Patent protection in our country, SuoFei Mr Wei will expire in 2024. However, according to media reports, the first patent in 2004 in China by is now facing the issue, put forward an application for a patent for the second year in 2008 and was refused by the state intellectual property office. Plus, India has produced SuoFei cloth wei generics, costs a mere 1% in the United States. These messages, once let domestic like LaoDing patients and pharmaceutical companies felt the hope. At present, there have been several domestic pharmaceutical research institutions to submit application for the clinical trials of a drug.

However, the adjustment of the concept of "new drug" make domestic SuoFei cloth wei generic production, new problems came into being. According to the previous policy, generic drugs already on the market abroad, can be registered as the third type of chemical drugs, enjoy a series of preferential policies in the review of the examination and approval, etc. Policy adjusted SuoFei cloth of the original, such as the third kind of chemical drugs ceases to be a new drug, even break through the patent barrier, also can only for approval to register as a domestically produced generic drugs, because the original "imitation" and "new drug" whether enjoy preferential policies will continue, became a land of "unknown".

Industry also look forward to more clear, not only includes the original third class of new drugs. Three-year, founder medical institute patent challenges of the German bayer final success. In may this year, moxifloxacin sodium chloride injection lose patent protection in China. Yi Chongqin said, domestic listed moxifloxacin sodium chloride injection, compared with the original product, the price will decrease sharply. But because the original drugs has been on sale in domestic and domestically produced generic drugs can only be registered as the sixth kind of chemical drugs. Founder medicine research institute to submit production request for approval, at present, ranked 4000th away waiting for approval to the queue. According to the current speed, the official on the market need, etc. More than a decade later.

Concept of experts and business people have said, after adjustment, our country's "new drug" range will shrink sharply, more drugs will be added to generics. Accordingly, to have certain innovation, is advantageous to the adjustment of industrial structure of generic drugs should be how to discriminate, speed up the review for examination and approval, be badly in need of a clear policy.

According to the reporter, the outline of policies are slowly emerging. On August 24 ~ 25, state drug administration in Shanghai held a national work conference on drug approval for examination and approval system reform, put forward the global innovation medicine will be classified as "no lamp" area, early intervention, and timely communication, to speed up the review of the examination and approval; Urgent clinical needs, help industrial transformation of drugs into the "green light" area, single line to speed up the review for approval. Experts say the most concern "green area" of the specific standards, especially need to be defined and clear as soon as possible.