As Asean members prepare for regional integration under the Asean Economic Community (AEC) in 2015, stakeholders in Thailand’s healthcare industry need to consider many issues in order to take full advantage of the opportunities.
The AEC aims to make Asean a single market and production base, with a free flow of goods, services, investment, skilled labour and freer flow of capital. This will pose major challenges, as well as increased opportunities, for Thai stakeholders. They will need to reposition themselves as effective and efficient operators within Asean as a whole and not simply within Thailand.
Harmonisation of pharmaceutical registration: Healthcare is one of 12 service industries to be liberalized under the AEC. The commitment to a single market and production base requires, among other things, tariff liberalization, removal of non-tariff barriers, harmonisation of product standards and technical regulations, and mutual recognition of test reports and certification.
To this end, through the Asean Pharmaceutical Product Working Group, member countries have started implementing the Asean Harmonisation on Pharmaceutical Registration. Under these new rules, Asean pharmaceutical manufacturers (and manufacturers outside Asean wishing to export their products into Asean) are required to prepare application dossiers in a common format in accordance with the guidelines of the Asean Common Technical Requirement (ACTR) on safety, quality and efficacy and the Asean Common Technical Dossier (ACTD) on other details.
The ACTR guidelines cover analytical validation, bio-availability and bio-equivalent studies (BA/BE), process validation, and stability data that comply with the standards set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.
The Thai Food and Drug Administration (FDA) has implemented the Asean Harmonisation rules voluntarily since 2008. These rules became effective on Jan 1, 2009.
The harmonisation rules will have an impact on both importers and manufacturers whose drug application dossiers have not been prepared in accordance with Asean guidelines (known as non-Asean drugs). Under the Thai Drug Act, B.E. 2522 (revised edition), drug application dossiers that were registered and received certificates before the Act came into effect could have been used until the expiration of the term of the certificate. This, in effect, meant a life-long certificate, since no expiry date was specified, unlike other countries where a five-year validity is the norm. Therefore, for drugs registered before Jan 1, 2009, the application dossiers will have to be adjusted in compliance with the Asean guidelines.
Furthermore, once the AEC takes effect, all pharmaceutical manufacturing premises in the region must comply with the Pharmaceutical Inspection Convention and Pharmaceutical Cooperation Scheme (PIC/S). Upgrading premises to meet PIC/S requirements should improve Thailand’s attractiveness as an investment location, but will also involve substantial costs and may have a significant impact on small and medium operators.
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