Hong Kong, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam
In most cases, the smaller Asian countries will not require local clinical studies, and will accept foreign clinical trial data during the registration process for both medical devices and pharmaceuticals. To register new drugs, applicants must also submit either a Free Sales Certificate or a Certificate of Pharmaceutical Product (CPP) issued by the Country of Origin (COO).
However, in some instances, a local clinical study may be required for registration approval. These local clinical trials generally adhere to the global good clinical practice guidelines (ICH-GCP). Various initiatives, such as the 1999 harmonization initiative (ASEAN Consultative Committee for Standards and Quality), have attempted to bridge the gap between the clinical trial requirements in these Asian countries and those around the world. For example, Taiwan has achieved this in part by providing GCP training, setting up a Joint Institutional Review Board (JIRB), and gradually improving the review process for local clinical trials.
Before local pharmaceutical clinical trials begin, regulatory agencies – such as Singapore’s Health Science Authority (HSA) and Taiwan’s Food and Drug Administration (TFDA) – oftentimes require product samples, a proposal for labeling, and pre-clinical documents, along with a series of Chemistry, Manufacturing, and Controls (CMC) documents.
Although some foreign companies may question the quality of the local clinical trials in the smaller Asian countries, they have some advantages over clinical trials in the more developed Asian countries. For example, the cost of conducting clinical trials in Thailand is much cheaper than in a country like South Korea. Furthermore, the approval times to initiate a clinical study in the smaller Asian countries are generally shorter than in some of the larger East Asian countries.
Each Asian country has a unique regulatory system and clinical research landscape, and it is essential to understand the different strategic approach to take in each country and have experience in dealing with the local regulatory agencies to ensure a successful clinical trial process. Pacific Bridge Medical has strong on-the-ground presence in Asia through our four local offices in the region. We can act as your contract research organization (CRO) or find and manage a highly qualified CRO on your behalf in each of the Asian countries. Our experts will assist you in navigating the regulatory requirements in each country to complete the clinical trials and obtain registration approval.
Contact us today for a consultation with our experts on your clinical trial needs in Asia.
Visit our Resource Center to view free webcasts and charts or read publications, news, and research reports on the Asia medical markets.
Related Blog Posts
Visit our Blog for more insight into key trends and regulations from the Asia medical markets, written by our leading consultants and researchers.