You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

February 23, 2012

One Area, One Rule: AEC Landscape for Regulatory Affairs

Subscribe to Updates
Informed Counsel

The formation of a single market and single production base by 2015 will permit companies within ASEAN member states to more freely move their capital and will serve to effectively break down existing trade barriers that currently stunt intra-regional trade within the ten-member bloc. The implementation of consistent standards within ASEAN countries for each product, including related rules and regulations that conform to international standards, will, in theory, ensure the removal of such trade barriers or obstacles.

“One Area, One Rule” is the term commonly used to describe the ASEAN Economic Community (AEC), which will officially be implemented by 2015. For several years, regulatory authorities in each ASEAN country have been embroiled in discussions on the main rules to implement across a range of tightly regulated sectors—including cosmetics, food, pharmaceuticals, and agricultural products—with a goal to achieving the objective of “One Standard, One Test, Implemented Everywhere.” But harmonization of the rules has not yet reached an advanced stage for all products.

An overview of the some of the harmonization rules that have already been implemented, along with those that are in the process of being put in place, is provided below.

One Harmonization Scheme for All

Cosmetics. On January 1, 2008, ASEAN member states implemented the ASEAN Harmonization Cosmetics Regulation Scheme. As a result, a streamlined system and an efficient registration process have replaced the previously chaotic system, and there is now just a solitary category for cosmetic products.

The Thai Food and Drug Administration (FDA) implemented a new online cosmetic product registration system on November 1, 2010. Registrations are mostly conducted online, which is less time consuming, and there is now only one category of products to be registered, namely, notification cosmetics.

Pharmaceuticals. One of the main concerns of member states was that each local FDA had different requirements for registering pharmaceutical products in each ASEAN country. Therefore, the pharmaceutical industry was one of the first industries pushing for the implementation of a harmonized regulatory scheme, to complement and facilitate the objective of developing an ASEAN Free Trade Area, and in particular, the elimination of technical barriers to trade posed by these regulations.

Following the ASEAN harmonization, on January 1, 2009, the Thai FDA implemented the ASEAN Common Technical Requirements and Dossier (ACTR/ ACTD) on Quality, Safety and Efficacy, which provides guidelines on analytical and process validation, stability studies, and bioavailability/bioequivalence.

Other amendments to local laws are also under consideration, so as to be in line with the upcoming AEC harmonization schemes. In addition, to facilitate the registration of products in each country, the Thai FDA is currently considering accepting bioequivalence studies that are conducted in foreign countries for generic products.

Agricultural products and livestock. Harmonization of the requirements for agricultural products is also well underway. For example, in 2006, the ASEAN Good Agricultural Practices for Fresh Fruit and Vegetables, or ASEAN GAP, was adopted as a standard for the production, harvesting, and post-harvest handling of fruits and vegetables in the region. Several other ASEAN harmonization standards have also been implemented, such as 13 criteria for the accreditation of livestock establishments and 3 criteria for the accreditation of livestock products.

Steps Toward Harmonization

Medical devices. Each member state has until 2014 to implement the new requirements established by the Medical Device Working Group, to finalize the harmonization process for all medical devices. This includes formulating a common definition for medical devices which is derived from the Global Harmonization Task Force definition, harmonizing the classification of the products (five classes based on the assessed risk of the products), developing a common list of international medical device standards to obtain similar quality assurance, and agreeing on a Common Submission Dossier Template (CSDT), among others.

In Thailand, discrepancies remain in the product registration process for medical devices, but these are now being addressed. For example, blood bags, which are usually classified in most other countries as medical devices, were previously categorized in Thailand as drugs. Due to a recent change in legislation, however, a blood bag will be classified as a medical device moving forward.

The Thai FDA has also announced that it will be considering the CSDT by 2012–2013, and preparations are underway for the implementation of the ASEAN Medical Device Directive (AMDD) in the next four years. The Thai FDA is now requiring local manufacturers’ facilities to obtain a Good Manufacturing Practice Certification, which is equivalent to international standards like ISO 13485.

Food. Food safety is the one of the main objectives of the AEC. Thus, in 2009, the AEC adopted the ASEAN Integrated Food Security Framework and Strategy Plan of Action for ASEAN Food Security.  The AEC is also considering using the Codex General Standards for Food Additives (GSFA) as the basis for harmonization.

The Thai FDA also intends to establish the Food Alert System of Thailand (FAST), in order to be linked up to the ASEAN Rapid Alert System for Food and Feed (ARASFF), when the AEC is implemented in 2015.

Conclusion

Implementation of the AEC will have a broad impact on ASEAN countries. Therefore, each ASEAN country needs to prepare itself for the implementation of both regulations and quality standards of goods in order to gain substantial economic benefits and show that it should be considered as a strong and open player in the ASEAN market. In the meantime, it will be important to monitor whether the AEC will move toward a more general harmonization system, such as the systems that have already been planned, with a view to becoming more like the European Union in regard to the protection of intellectual property rights.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

August 10, 2026
On June 17, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 10 of 2026 on Nutritional Information on Processed Food Labels. The new regulation, which revokes three previous nutrition labeling regulations, introduces several notable changes affecting food and beverage manufacturers, importers, and distributors. These changes range from updated nutrient reference values and serving-size requirements to the introduction of the Nutri-Level front-of-pack labeling system for certain beverage products. Businesses operating in Indonesia should carefully review these developments and assess their products’ compliance with the new requirements during the transition period. Implementation of the Nutri-Level Labeling System To implement the recently issued decree on Nutri-Level labeling, BPOM Regulation No. 10 of 2026 stipulates the requirements to implement the Nutri-Level labeling system on the front-of-pack. Under the new framework, ready-to-drink beverages, powdered beverages, and liquid or solid concentrates are required to display Nutri-Level labeling on the front label of their packaging. The Nutri-Level labeling system classifies products into color-coded levels A through D based on their sugar, sodium, and total fat content. The applicable Nutri-Level is determined based on the lowest level measured in the assessment of sugar, sodium, and total fat content. For products classified as level C or D, the Nutri-Level label must be accompanied by information on the relevant sugar, sodium, and total fat content per 100 ml of the ready-to-consume product. Products classified as level A or B may either display only the Nutri-Level designation or display the Nutri-Level together with the relevant nutritional information per 100 ml. Minimum Vitamin and Mineral Content Required for Declaration BPOM Regulation No. 10 of 2026 introduces a stricter threshold for the declaration of vitamins and minerals in the nutritional value information section (ING). Vitamins or minerals may only be declared if they are present at a
Read More
August 10, 2026
The drug registration process in Vietnam will be simplified, particularly for foreign applicants, following the recent issuance by Vietnam’s Ministry of Health (MOH) of a new circular that is expected to reduce administrative hurdles. Circular No. 32/2026/TT-BYT on the registration of drugs and medicinal ingredients (Circular 32) was issued on July 29, 2026, and will take effect on October 1, 2026, replacing Circular No. 12/2025/TT-BYT. Key provisions of the new circular are discussed below. Five-Year Data Exclusivity and Five-Month Public Disclosure Framework Circular 32 updates data protection guidelines by explicitly referencing Article 128 of the amended Intellectual Property Law, which sets out that new drugs supported by clinical trial data submitted for the first time will be granted a five-year data exclusivity period from the date of the initial marketing authorization (MA) approval. Subsequent applications that rely on the originator’s protected data will not be eligible for approval from the date of submission of the originator’s registration dossier until five years after the first MA is granted. Furthermore, in accordance with the new regulations, the regulatory authority must publicly disclose information on subsequent applications five months before the granting of MA, providing originator companies with an opportunity to exercise and enforce their intellectual property rights. Simplified Requirements for Foreign Legal Documents Circular 32 expands the circumstances under which legal documents issued by foreign authorities are exempt from consular legalization and authenticity verification requirements. Specifically, such documents may be exempt if the Drug Administration of Vietnam (DAV) is able to verify their authenticity directly through official electronic means, including written confirmation or email correspondence sent directly to the MOH by the competent foreign authority, or publicly accessible English-language databases maintained by recognized foreign regulatory authorities. In addition, the new circular permits the submission of electronic notarized copies of legal documents
Read More
July 24, 2026
As food innovation continues to accelerate, manufacturers are increasingly introducing ingredients derived from new sources, produced using novel technologies, or lacking a significant history of human consumption. While these innovations create new opportunities for the food industry, they also raise important questions regarding consumer safety. For this reason, many jurisdictions, including Thailand, the European Union, Australia and New Zealand, Canada, and Singapore, require a premarket safety assessment for novel food ingredients before they can be placed on the market. The objective of this assessment is to ensure that each ingredient is safe for its intended use and level of consumption, does not present toxicological, allergenic, microbiological, or nutritional concerns, and will not mislead consumers. Scientific authorities typically evaluate the ingredient’s identity, manufacturing process, composition, specifications, anticipated dietary exposure, toxicological information, nutritional impact, and history of use before determining whether it can be marketed. Against this background, the Thai Food and Drug Administration (FDA) recently took an important step toward improving regulatory transparency by publishing, for the first time, a consolidated public list of substances that have successfully completed the Thai FDA’s safety assessment process, including substances determined to be novel foods and those determined not to fall within the novel food category. The list identifies the approved substances, the corresponding manufacturers or importers, approval dates, and the approved conditions of use. Although the publication does not change the existing legal framework governing novel food approvals, it provides businesses with greater visibility into the Thai FDA’s regulatory precedents and the types of substances that have previously been accepted through the safety assessment process. The full announcement is available on the Thai FDA’s website. As the list is now publicly available, it also provides useful insight into the types of substances that have successfully completed the Thai FDA’s safety assessment process.
Read More
July 24, 2026
For businesses in Thailand’s regulated industries, the problem of “too many licenses” is one of the most familiar hurdles to getting a product to market. Take a simple example: importing the materials necessary to sell teriyaki chicken skewers. To legally do this, a business may need approvals from several different agencies—separate permits for the chicken (Department of Livestock Development), the dipping sauce (Thai FDA), the wooden skewers (Department of Forestry), and other ingredients, each under a different authority. This kind of overlap is often cited to argue for a “regulatory guillotine”—a systematic review to cut outdated or duplicative rules that slow investment and business activity. The Facilitation of Licensing and Public Service Consideration Act B.E. 2569 (2026) (Licensing Facilitation Act 2026) is Thailand’s most significant response yet to that concern. This article looks at the Facilitation Act 2026 through a life sciences and regulatory affairs lens—what it may mean for the manufacturers, importers, and distributors of food, drugs, medical devices, cosmetics, and similar products who routinely deal with several regulators to bring a single product to market. The Super License: One Approval Standing in for Many The reform with the clearest potential for regulated-product businesses is the law’s “super license” mechanism, referred to as a “main license” in the statute. Once a business obtains the main license for a regulated activity, it is automatically deemed to hold all related sublicenses issued by other agencies for that same activity, provided the activity has been designated as eligible in the Government Gazette. The Licensing Facilitation Act 2026 also creates a central application center, allowing applicants to submit a single application and pay all relevant fees at one point of contact, with the center routing the application to each agency through a shared information system. The potential benefits of this for businesses
Read More