[Asia Economy Reporter Lee Chun-hee] It is pointed out that regulatory authorities need to have the appropriate capabilities and provide close support from the early research and development (R&D) stages to foster the rapidly growing pharmaceutical and bio industry following the COVID-19 pandemic.
The Korea Pharmaceutical and Bio-Pharma Manufacturers Association announced on the afternoon of the 13th that it will hold the "Biohealth Industry Promotion New Year Dialogue" to create an environment for global innovative drug development by strengthening expertise in drug approval review and quality evaluation. The event will be broadcast live on the association's YouTube channel.
The presentations at this dialogue will be delivered by Hwang Man-soon, CEO of Korea Investment Partners, and Oh Il-hwan, professor at the Catholic University School of Medicine (Chairman of the Central Pharmaceutical Review Committee). CEO Hwang will speak on the topic "Current Status and Future of Global Pharmaceutical and Bio Industry - How Can Regulatory Science Become a Growth Partner?" and Professor Oh will present on "Regulatory Science for Bio Innovation in the Fourth Industrial Revolution Era."
Following the presentations, the dialogue will be chaired by Won Hee-mok, chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, with participants including ▲ Kim Kang-lip, Commissioner of the Ministry of Food and Drug Safety ▲ Lee Hyung-hoon, Director General of Health Industry Policy Bureau, Ministry of Health and Welfare ▲ Kim Young-man, Director of Bio Convergence Industry Division, Ministry of Trade, Industry and Energy ▲ Jang Shin-jae, President of Celltrion ▲ Ahn Jae-yong, President of SK Bioscience ▲ Kwon Se-chang, President of Hanmi Pharmaceutical ▲ Eom Dae-sik, Chairman of Dong-A ST ▲ Yoon Sung-tae, Vice Chairman of Huons Global, among others.
South Korea is evaluated to have the potential to leap into the global biohealth market, having recorded technology export achievements exceeding approximately 13 trillion won last year and ranking 6th worldwide with a 3.7% share in global clinical trials.
However, compared to this, the Ministry of Food and Drug Safety's personnel for approval and review in the medical products sector was only 333 as of 2019 (176 public officials and 157 contract workers). This is vastly insufficient compared to major global pharmaceutical regulatory authorities such as the U.S. Food and Drug Administration (FDA) with 8,398 personnel, the European Medicines Agency (EMA) with about 4,000, Health Canada (HC) with 1,160, and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) with 561.
In particular, to prepare for the COVID-19 pandemic and the post-COVID era, securing high-quality personnel for rapid approval is crucial, but the absolute number of personnel is insufficient, and the high proportion of unstable contract workers limits the recruitment of experts, raising concerns.
Therefore, this New Year dialogue was organized to diagnose the current status of drug approval review and quality evaluation by regulatory authorities and to seek reasonable measures to advance the pharmaceutical and bio industry and accelerate entry into the global market.
A representative of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association said, "For the development of the pharmaceutical and bio industry, not only innovation in the industry but also regulatory authorities responsible for approving, managing, and supporting products require high expertise and promptness," adding, "This New Year dialogue will be an opportunity to discuss creating an ecosystem for fostering the biohealth industry."
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