The pharmaceutical industry castigates the lack of support for the API sector


Pharmaceutical industry officials have criticized the government for providing almost no support to bolster the local active pharmaceutical ingredient (API) sector.

The Korea Pharmaceutical and Biopharmaceutical Manufacturers Association (KPBMA) and Representative Nam In-soon of the Democratic Party held a debate on revitalizing Korea’s API industry on Tuesday at the Members’ Office Building. National Assembly in Seoul.

Kim Kun-hoon (left), director of the Health Industry Development Division at the Ministry of Health and Welfare, and Moon Eun-hee, director of the Pharmaceutical Policy Division at the Ministry of Food and Pharmaceutical Safety, participate in a discussion on how to support the active pharmaceutical ingredient (API) industry in Seoul on Tuesday.

Speakers included Jung Soon-kyu, Senior Researcher at Korea Health Industry Development Institute, Kim Min-kwon, Director of Chong Kun Dang’s International Business Team, Lee Young-mi, Vice -president of the Korea Pharmaceutical Industry Association, and Ahn Myung-soo, division head at the Korea Orphan & Essential Drug Center (KOEDC).

They pointed out that the domestic API sector needs the active political support of the government, the formation of private-public governance and deregulation. They have repeatedly condemned the lack of government measures to support the growth of the API industry.

Responding to criticism, Kim Kun-hoon, director of the health industry development division at the Ministry of Health and Welfare, admitted that government support has focused only on clinical trials. late stage or the discovery of drug candidates.

“We learned that the API industry needs government support to develop production processes and establish manufacturing facilities. Therefore, we will be looking for measures in detail,” Kim said.

However, he was skeptical of the industry’s most requested favor request for the pricing of API drugs made in Korea.

Currently, the government guarantees 68% of the brand name drug price for a generic drug manufactured from the generic drug manufacturer’s API for one year after the first release of a generic drug. However, industry officials are calling on the government to expand the scope of generic drugs from those using “self-made APIs” to “Korea-made APIs.” They are also demanding an extension of the drug price privilege period to more than one year.

Kim said he knew the pharmaceutical industry was unhappy with the government’s drug pricing policy. Still, he said the government must treat local and foreign drugs without discrimination because of free trade agreements.

He added that the government will soon raise a mega fund for pharmaceuticals and not only finished drug makers but also API makers will get funding.

Moon Eun-hee, director of the pharmaceutical policy division at the Ministry of Food and Drug Safety (MFDS), explained why the ministry should only focus its policy support on particular APIs.

“Since the urea shortage debacle, the Ministry of Economy and Finance has been monitoring supply and demand for key economic goods, including APIs. And the MFDS is monitoring that,” Moon said.

Since the MFDS has limits on supporting all APIs, the ministry has prioritized supporting only certain APIs, she said. “That’s why we are considering more support for national essential medicines APIs,” she added.

Under the Pharmaceutical Affairs Act, the Minister for Health and Welfare and the Designated Minister for Food and Drug Safety designate essential drugs through consultation. So far, the government has named 511 essential medicines.

Moon said the MFDS had received about 120 reports of halting the supply of essential drugs in the past three years, mainly due to the shortage of imported raw materials.

To reduce reliance on imported APIs, MFDS is pushing for a study to support innovative technology for APIs. KOEDC will lead the study and KPBMA will participate as a trusted research institute. The study will cost 5 billion won ($3.8 million).

According to Moon, the study aims to support the technology to produce essential national medicines. “The government will select APIs for essential national medicines that are expected to pose a risk to public health due to unstable supply and develop technology to produce these APIs,” she said.

“After the development of the production technology, we will grant the license to a company committed to producing and supplying this drug and providing administrative support in the approval process,” she added.

Moon stressed that the MFDS actively communicates with the industry to resolve trade difficulties.

The government had not recognized several API manufacturers of approved drugs because different manufacturers have different quality standards. However, the MFDS plans to recognize multiple API manufacturers as long as the finished drugs are of the same quality, Moon said.


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