An association of 10 nations in Southeast Asia crafted standards governing traditional medicines and health supplements. The development furthers a broader plan to create a regional economy and positions products within member countries to compete internationally.
The Association of Southeast Asian Nations (ASEAN) developed and endorsed standards governing GMPs (good manufacturing practices), maximum levels of vitamins and minerals, and labeling requirements—paving the way for member nations to eventually change their laws and create a unified standards regime.
As of fall 2014, only two other standards—limits on contaminants and safety substantiation requirements—are awaiting final endorsement from a health supplements committee before the process is complete. The ASEAN Consultative Committee on Standards and Quality Product Working Group for Traditional Medicine and Health Supplements (ACCSQ TMHS PWG) was expected to endorse the standards during a November meeting in Lao PDR.
The technical standards will become part of agreements that ASEAN ministers will sign at the end of 2015, said Wai Mun Poon, regional regulatory affairs manager in Singapore for EAS Strategic Advice. EAS is a global regulatory and strategic advisory services firm that works with trade associations, government bodies and companies.
“After signing the agreement, each member state must change its national laws to meet the technical requirements," Poon said, and ACCSQ TMHS PWG has set December 2020 as the deadline.
Current differences in standards between member nations impede trade, increasing the cost of conducting business in the region, said Boon-Hwa Lim, head of regulatory affairs, Asia Pacific, DSM Nutritional Products. For instance, Lim said companies must supply different formulations in ASEAN to accommodate distinct standards governing maximum levels of vitamins and minerals.
“The harmonization of standards in ASEAN would, in the long term, help to create a single market of more than 600 million combined population with a fast-growing middle class of increased purchasing power for supplements," Lim said. “The efficiencies of a single market will encourage companies to establish their production base in the region due to the ease of doing business, costs savings resulting from harmonized regulation and increased market access for their products."
Established in 1967 to promote political security in the region, ASEAN was originally comprised of five members: Indonesia, Malaysia, Philippines, Singapore and Thailand. In the 1990s, five other countries joined: Brunei Darussalam, Cambodia, Lao PDR, Myanmar and Vietnam.
The countries are in various stages of economic development and have divergent regimes governing traditional medicines and health supplements. Seven years ago, ASEAN formed an economy community that set a goal to create a single market and production base by 2015, Poon said. “One of the key areas they are looking at is encouraging free flow of goods by eliminating technical barriers to trade, which could be achieved by harmonizing the standards in the region," she said.
The notion of a regulated and distinct supplement industry is still a novel concept in much of Southeast Asia. A number of nations there have no specific guidelines for health supplements, including Cambodia, Lao PDR, Myanmar, Philippines and Vietnam, according to a presentation EAS made during Vitafoods Asia 2014 in Hong Kong. In seven of the 10 member nations, health supplements are regulated by drug agencies, and cutting through red tape to bring a product to market can take several months, the presentation indicated.
Poon said most member nations require premarket approvals. That may not change even after nations update their laws to meet ASEAN’s standards because each country will still determine how to regulate the market.
“It is important for companies to take note that though ASEAN will be using the same standards/requirements, they will still need to seek approval from each countries' authorities in order to bring the products into the market," Poon said.
Read more from Poon on regulatory harmonization in INSIDER’s Vitafoods Asia 2014 Report.