New GMP Specification Announces Immediate Pricing Game for Pharmaceutical Firms

After a delay of more than one year, the business club announced on January 17th that the new version of the GMP standard ("Pharmaceutical Production Quality Management Practice") that was formulated in accordance with EU standards is finally expected to be finally announced. The reporter learned from the authoritative sources on the 13th that the new version of the GMP specification that has been brewing for 3 years has all been completed. At present, it has been submitted to the Ministry of Health according to the procedure and is waiting for the final announcement.

At this time, it has been more than a year since the work plan of the State Food and Drug Administration had planned to release this document by the end of 2009.

“The repeated delays in the new version of GMP are due to the large internal and external resistance.” The aforementioned sources revealed to reporters, “Even in the current signing stage, it is still a bit of a catastrophe.”

This reporter learned that because this round of upgrading is likely to involve more than 13,000 pharmaceutical companies in the country, and GMP certification is directly related to whether the company can obtain a production license, affecting the whole body. Adding a previous version of GMP has caused a lot of legacy problems left over from production capacity. For a long time, the opinions of the industry on the introduction of the new version of GMP are not uniform.

The relevant person in charge of the Department of Drug Safety Supervision of the State Food and Drug Administration in charge of this work has also stated in public that it is expected that the implementation of the new regulations will shut down at least 500 SMEs with sluggish operations in the country, while compliance companies will only invest in hardware. 200 billion to 300 billion yuan is needed.

On the other hand, it is precisely because the last GMP mandatory certification has many parts that need improvement, the launch of the new version of GMP is even more urgent.

Although the GMP document has not yet been announced, some changes in the new document have been determined in comparison with the 1998 version of GMP. For example, the company will place special emphasis on the continuous and dynamic supervision of the company's products after listing, with emphasis on management and personnel. Other "software" controls, more emphasis on dynamic monitoring of product quality.

With the countdown of the new GMP announcement, its emphasis on the new content of drug quality has once again triggered the game of pricing and quality of drugs in the industry.

On December 12 last year, the National Development and Reform Commission formally lowered the maximum retail price of individually priced varieties dominated by foreign-funded products. The average price cut was 19%, and many multinational pharmaceutical company products were involved.

Some commentators believe that the national pricing department has a clear symbolic significance for the “opening of foreign drug companies” that have always enjoyed price protection “super national treatment”. The high price that foreign drug companies stick to will be loosened.

In response, the China Association of Enterprises with Foreign Investment Drug Development and Development Industry Committee (RDPAC) responded by stating: “The support of the National Development and Reform Commission to gradually rationalize the relationship between pharmaceutical prices, reduce drug prices, and promote fair competition in the market is also in favor of various reform attempts. The National Development and Reform Commission gradually reduced the original idea of ​​developing drug and generic drug spreads in stages."

However, it also pointed out that compared with international comparisons, the ex-factory price of generic drugs in China is 22% to 30% of the overall international price level. Adjusting the prices of original research drugs based on their prices will inhibit the investment in the industry's quality system, which is detrimental to China's pharmaceutical market and pharmaceutical industry. The healthy development of the industry.

As the most important affiliate of multinational pharmaceutical companies in China, RDPAC currently has 37 international pharmaceutical giants such as Novartis, AstraZeneca, and Novo Nordisk.

According to McKinsey's research, the current price of generic drugs in China is only 20% to 30% of the price of generic drugs in the global market, and the original research price is only 50% of the developed market and 70% of the emerging markets in Asia. On average, the production and retail prices of the original Chinese medicines are lower than the international market prices.

RDPAC President Liu Zhenxian suggested that he hopes that the national pricing will be based on quality-based price adjustment policies. The new drug will gradually try to be more suitable for China's pharmacoeconomics value pricing and innovative new drug investment environment and reduce market access restrictions, reduce cost pricing, and hopefully The role of the market mechanism should be brought into play; at the same time, various innovative drugs should be encouraged and domestic enterprises should be encouraged to innovate.

However, the problem is that, at least at this stage, domestic companies obviously do not have an advantage - because the new version of the quality management requirements to strengthen, with domestic companies currently on average only 5% of the quality control technology, from the international average of 15% The gap between the levels is far, and the overall estimate is that the quality control personnel of production companies need to be doubled, and the gap of 100,000 people needs to be filled.