Around The Globe

Regulatory Harmonization and Recognition Continue in ASEAN

Jin Shun
Regulatory Affairs APAC
Abbott EPD


ounded in 1967, ASEAN is currently the sixth largest global economy, with the third largest labor force and a Gross Domestic Product (GDP) of US$ 2.55 trillion or 6.2 percent of global GDP. ASEAN is highly diverse in terms of ethnicity, social demography, and social-economics. The region is developing fast with an ever-changing regulatory environment that poses both challenges and opportunities to its stakeholders.

The Pharmaceutical Product Working Group (PPWG) is one of the active working groups under the ASEAN Consultative Committee for Standards and Quality (ACCSQ). Its objective is to develop harmonization schemes for ASEAN member countries’ pharmaceutical regulations to complement and facilitate the objective of the ASEAN Free Trade Area (AFTA) – particularly, elimination of technical barriers to trade posed by regulations, but without compromising product quality, efficacy, and safety.

One of harmonization initiatives emanating from PPWG was the ASEAN Common Technical Document (ACTD) introduced in 2006 to harmonize document requirements in ASEAN. Considering that the majority of pharmaceuticals registered in ASEAN are generics, and that health authorities mainly review the quality module, it was agreed to consolidate the quality data under a single module to facilitate review, instead of separating this information over two modules like in the ICH-CTD (where M2 contains the Quality Overall Summary and M3 contains the body of Quality data). Some ASEAN Member States (AMS) have reinforced ACTD for submission as of 2008, while others still accept ICH CTD as its alternative. However, the different ACTD format compared with the ICH-CTD format creates a challenge for multinational companies. Another regulatory challenge lies in constant updates in Member States’ regulations. For example, upon the recent update and implementation of the pharmaceutical law in Vietnam, industry must continue to keep abreast of such changes as in-use shelf-life labelling information. Meanwhile, the delay in (and sometimes the lack of) implementation details always causes confusion and difficulty for industry. Regulatory agency interpretation is always needed.

Indonesia’s introduction of serialization is a good example of another challenge. In 2017, the Regulatory Authority in Indonesia (BPOM) decided to start pilot implementation of serialization to track pharmaceutical products in order to fight counterfeits – the first ASEAN Member State to implement serialization. However, the standard BPOM decided to use differs from international practice and even from closely neighboring countries such as Korea and China. It is encouraging to see BPOM listen to different stakeholders and accept alternative standards. However, there is now uncertainty in the supply chain as companies invest and modify their production lines for the Indonesian market. Introducing such country-specific requirements creates additional hurdles for launching and marketing medicinal products simultaneously across the region.

ASEAN Member States
Brunei Darussalam, Cambodia, Indonesia, 
Lao PDR, Malaysia, Myanmar, Philippines, 
Singapore, Thailand, Viet Nam

Meanwhile, Mutual Recognition Agreements (MRAs) have been signed by all AMS for GMP inspections and the BA/BE study report format; ASEAN guidelines were implemented for stability studies, process validation, validation of analytical methods, variation, and BA/BE studies, and a few ICH safety and efficacy guidelines have been adopted in ASEAN as well. Beginning in 2015 and in partnership with the World Health Organization (WHO), the Supporting the Implementation of ASEAN Harmonized Requirements (SIHAR) project for Drug Registration was initiated in the PPWG, with the ASEAN Joint Assessment (JA) procedure kicking off as one of the SIHAR project initiatives. The JA’s purpose is to strengthen national regulatory agencies’ technical capacity and to foster mutual trust and reliance among AMS. More importantly, the JA procedure will facilitate review of priority medicines throughout ASEAN while respecting existing national decision-making processes. It is expected that the success of JA will achieve harmonious interpretation of guidelines, strengthen capacity of AMS in reviewing and approving medicines within the best possible assessment timelines, build trust and mutual understanding among AMS, and improve workload and technical resources. The JA pilot period of up to two years started in January 2017.

Harmonization opportunities are not only initiated within ASEAN but also emerge from dynamic changes of the regulatory environment outside the region. In 2017, with the recent ICH expansion, Singapore became the first ICH country in ASEAN. Introducing the eCTD provides opportunity to adapt to the ICH-CTD format. This was realized in Thailand when introducing eCTD in 2015. In addition, the concept of regulatory reliance (e.g., the Australia, Canada, Singapore, Switzerland [ACSS] Consortium) addresses resource and capacity gaps for some regulatory bodies. Regulatory science training and education are currently offered through various platforms with support from the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee) (APEC RHSC), the ICH and WHO, academia, and other regulatory bodies outside ASEAN such as Japan’s PMDA.

Regulatory challenges will always exist and new challenges will always emerge. All ASEAN stakeholders should explore practical models of partnership beyond their current regulatory framework to continue leveraging these opportunities to enhance collaborations to meet patient needs.

References available upon request.

Acknowledgements: Special thanks to Kum Cheun Wong, Head Asia Pacific, Regulatory & Development Policy, Novartis, for providing supporting information.