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

March 14, 2012

Towards Greater Harmonisation – The View from Southeast Asia

World Intellectual Property Review

The 10 nation members of the Association of Southeast Asian Nations (ASEAN) have committed to implement an ASEAN Economic Community (AEC) by 2015. As of January 1, 2010, with the full implementation of the ASEAN Free Trade Agreement (now called the ASEAN Trade in Goods Agreement), the trading bloc has created a single market of more than 600 million people, making it the world’s ninth largest economy, with a GDP growth of 7.5 percent.

Foreign direct investment into ASEAN rose to $76 billion in 2010, doubling the 2009 level. Comparisons to EU economic integration are frequent, but unlike that merged economy, ASEAN lacks singular regulation and harmonised rules and regulations. Among the key challenges posed by integration, ASEAN members will need to implement an effective system for the registration, enforcement and commercialisation of intellectual property (IP) within the AEC.

Current plan

Although the development of IP laws and enforcement mechanisms differ from one member state to another, ASEAN recognises the importance of effective IP policy, which must be consistently implemented in all member states. In 1995, ASEAN adopted the IP Rights Action Plan, which provides a framework for establishing effective IP policy in the region. The ASEAN Working Group on IP Cooperation (AWGIPC) was commissioned to oversee development of the action plan. The first phase of implementation ran from 2004 to 2010, and was aimed at IP creation efforts, public recognition and awareness of IP concepts and setting up regional enforcement frameworks.

The second phase of the action plan (from 2011 to 2015) is aimed at transforming ASEAN into an innovative and competitive region through the use of IP. In addition to carrying on from the three goals of the first phase, the second phase has addressed additional issues of IP harmonisation at the IP office level and the preparation for member states’ participation in global IP systems.

In light of this, significant improvements can be expected in the IP field within the next few years. For each type of IP, the AEC harmonisation may have several implications for protection, use and enforcement of an IP asset. In particular, the implications for trademarks, patents, and copyright are likely to have the largest impact on businesses in the region.

Trademarks

The AEC harmonisation plan for trademarks will be based primarily on the Madrid Protocol. Unlike the EU model, ASEAN’s integration plan for trademarks does not currently include a Community Trademark (CTM) scheme. According to the action plan, ASEAN members are required to accede to the Madrid Protocol by 2015. At present, only Singapore and Vietnam are members of the Madrid Protocol. Thailand has been working toward accession for several years, and is expected to join by 2015.

Patents

Importantly, the AEC envisions that all countries will become members of the Patent Cooperation Treaty (PCT) by 2015. Currently, four ASEAN member states have not joined (Brunei Darussalam, Cambodia, Laos, and Myanmar). Member states are charged with the responsibility to issue appropriate guidelines for PCT implementation in their country, and to amend any relevant legislation. AEC IP harmonisation strongly advocates implementation of the ASEAN Patent Examination Cooperation (ASPEC) system. It is hoped that the system will be fully operational by 2012, and will be used for 5 percent of all patent applications at this time. Other plans include the establishment of a regional network of at least 20 regional patent libraries to increase access to global scientific information.

Patent office capacity building is a specific AEC IP harmonisation goal, with training programmes for patent examiners to feature heavily in coming years. Various international patent offices have committed to providing training and best practice recommendations, with ASEAN patent examiners receiving training in neighbouring patent offices. Of note is plant variety protection, with Singapore and Vietnam, which have joined the International Union for the Protection of New Varieties of Plants (UPOV), expected to share their experience to help other member states bring their plant variety protection regimes up to international standards.

Copyright

Copyright harmonisation has received less emphasis than has been given to trademarks or patents, but it does feature in the action plan, with member states encouraged to undertake studies on the contributions of copyright industries to their economies and then share those conclusions with other members, including uniform recordal procedures. Thailand is taking the lead under the AEC in sharing information on how to build and operate collecting societies for effective use of copyright.

Conclusion

ASEAN IP offices have for years faced difficulties such as outdated office infrastructures, insufficiently trained examiners, tremendous backlogs of patent and trademark applications and, of course, rampant IP infringement. The AEC is striving to develop the necessary framework for regional cooperation in many areas of IP. The framework goals, if met, will not only improve regional cooperation, but will achieve harmonisation on some legal facets of IP and will help to bring many IP regimes up to best practice international standards. This will allow stakeholders in the member states to capitalise better on their untapped IP assets and, we hope, serve as a catalyst to improve innovation and encourage technological solutions to what are certain to be daunting, yet exciting, challenges to a rising integrated economy.


ASEAN FDAs – A harmonisation model for IP?

While harmonisation of IP registration systems within the 10 nations of ASEAN may be a few years in the making, regional Food & Drug Administrations (FDAs) and Departments of Agriculture have already begun to streamline and harmonise registration procedures.

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.

Pharmaceuticals. While currently each local FDA has different requirements for registering pharmaceutical products in each ASEAN country, the pharmaceutical industry is leading the way for the implementation of a harmonised regulatory scheme which aims to eliminate technical barriers to trade. The various FDAs have 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.

Medical devices. Each member state has until 2014 to implement the new requirements established by the Medical Device Working Group, to finalise the harmonisation process for all medical devices.

Food. In 2009, the AEC adopted the ASEAN Integrated Food Security Framework and Strategy Plan of Action for ASEAN Food Security and is currently considering using the Codex General Standards for Food Additives (GSFA) as the basis for harmonisation.

Agricultural products and livestock. Harmonisation of agricultural products is also well underway, with the 2006 ASEAN Good Agricultural Practices for Fresh Fruit and Vegetables (ASEAN GAP) adopted as a standard for the production, harvesting, and post-harvest handling of fruits and vegetables in the region. Other harmonisation standards include accreditation of livestock establishments and livestock products.

RELATED INSIGHTS​ 

July 13, 2026
Indonesia’s Halal Product Assurance Agency (BPJPH) has issued new regulations establishing clearer procedures for imposing administrative sanctions on businesses that violate halal product assurance requirements. BPJPH Regulation No. 2 of 2026 on the Imposition of Administrative Sanctions for Violations of Halal Product Assurance Implementation, issued on June 5, 2026, strengthens Indonesia’s halal compliance framework, as mandated under Law No. 33 of 2014 on Halal Product Assurance and Government Regulation No. 42 of 2024 on the Implementation of Halal Product Assurance. BPJPH Regulation No. 2/2026 also supports the upcoming mandatory halal compliance deadline of October 17, 2026, which will apply to a broad range of products and services, including imported food and beverages, slaughtering products and services, natural and quasi-drugs, health supplements, cosmetics, chemical and genetically engineered products, clothing and accessories, household goods, prayer equipment, stationery, and class A medical devices. Scope BPJPH is authorized to impose administrative sanctions for violations of halal product assurance requirements committed by businesses, halal inspection agencies (LPH), halal auditors, halal product process companion institutions (lembaga pendamping PPH), and halal product process companions (pendamping PPH). The head of BPJPH has authority to determine, cancel, or amend the imposition of administrative sanctions, including upon receipt of objections. This authority covers revocation of Halal Certificates (including foreign halal certificate registration numbers), withdrawal of goods from circulation, freezing of LPH operations, freezing of halal product process companion institutions, revocation of PPH companion institution registration numbers, revocation of halal auditor registration numbers, and revocation of LPH accreditation status. Administrative Sanctions Businesses may be subject to any of the following administrative sanctions: Written warning; Administrative fine; Revocation of the halal certificate, including revocation of foreign halal certificate registration numbers; and Withdrawal of goods from circulation. The regulation sets out the types of violations that may trigger these sanctions, with each
July 1, 2026
Obtaining marketing authorization is a fundamental requirement for bringing pharmaceutical products to the Thai market. Companies must navigate the Thai Food and Drug Administration’s registration procedures while also complying with post-approval pharmacovigilance obligations, licensing requirements for manufacturing and importation, data protection rules, and other regulatory requirements. This guide provides an overview of Thailand’s regulatory framework for pharmaceutical marketing authorization, including available registration pathways, review timelines, application fees, postmarketing surveillance obligations, licensing requirements, exemptions, data exclusivity, freedom of information, and parallel import considerations. It is intended as a practical reference for pharmaceutical companies, regulatory affairs professionals, and others involved in bringing medicinal products to the Thai market. Download the guide below for a concise overview of the current requirements and procedures governing pharmaceutical marketing authorization in Thailand.
June 24, 2026
Patent enablement requirements are provided under Article 102 of Vietnam’s Law on Intellectual Property (IP Law). In particular, a patent specification must “fully and clearly disclose the nature of the invention to such an extent that, based on the specification, a person having ordinary skill in the relevant art can implement the invention.” In pharmaceutical and biotechnology patents, this requirement is more complicated and subject to more rigorous assessment. The Patent Examination Guidelines (Guidelines) of the Intellectual Property Office of Vietnam (IP Office) were amended in March 2026 to introduce Annexes III and IV for the pharmaceutical and biotechnology sectors, in which Annex III provides detailed guidelines on the assessment of specification requirements. These amendments were made under a project for strengthening capacity in industrial property examination between the Japan International Cooperation Agency (JICA) and the IP Office. Annex III provides detailed instructions on how examiners assess enablement in a pharmaceutical or biotechnology application, and offers examples of acceptable and unacceptable descriptions with regard to the enablement aspect. Enablement Requirements in Pharma and Biotech Patents Article 12.7 of Circular 10/2026/TT-BKHCN (Circular 10) adds to the requirements of Article 102 of the IP Law that the description must demonstrate the novelty, inventive step, and industrial applicability of the technical solution. For pharmaceutical composition subject matters, Article 12.9 of Circular 10 sets out that the description must present the results of clinical trials and/or the pharmacological effects of the claimed pharmaceutical composition, and must include at least the following information: Substance/mixture used. Testing method (system) employed. Information on the test results. Correlation between the pharmacological effects obtained from the tests and the application of the pharmaceutical product in the prevention, diagnosis, and treatment of diseases. The Guidelines note that pharmacological study results should be presented in a quantified manner, and pharmacological
June 19, 2026
For the first time, Thailand’s Food and Drug Administration (FDA) has published a consolidated list identifying all substances that have successfully passed its novel food safety evaluation process. The list is a step forward in regulatory transparency, but it also highlights a feature of the Thai regime that food companies often overlook: each approval is tied exclusively to the company that applied for it. A substance’s appearance on the list does not give other companies the green light to use it. This article examines the structure of Thailand’s novel food approval framework, the implications of applicant exclusivity, and the strategic choices it requires of food companies looking to bring novel ingredients to the Thai market. Thai FDA Food Safety Evaluation Framework Notification No. 376 of the Ministry of Public Health requires novel food substances to undergo a food safety assessment, with an exemption only for novel foods manufactured exclusively for export. The framework also encompasses “foods that do not qualify as novel foods” but which present characteristics warranting a safety evaluation, such as differing quality standards, increased serving sizes, or applications in specific food categories, where such changes affect consumption levels, nutritional value, or consumer safety. The recently published list of foods that passed the safety evaluation by the Thai FDA is structured by substance category and identifies the approved company (domestic manufacturer or importer), country of origin, substance name and trade name, approved purpose of use, and date of the Thai FDA’s approval notification certificate. A notable feature of Thailand’s novel food regime is that the approval result is tied exclusively to the company that submitted the application. Publication of the consolidated list does not constitute a general authorization to use the approved substances. The Thai FDA’s approval certificate specifies the approved conditions of use and the requirements