Asian countries offer great market potential and value as clinical trial sites but they also vary in their regulatory regimes and trial conduct processes. Here, we examine the current state of play in two emerging markets, China and Thailand.
China – Reforms improve clinical trial review times
The China Food and Drug Administration (CFDA) is the regulatory authority responsible for clinical trial oversight, approval, and inspections for drugs to be registered in China. Under its auspices, the Center for Drug Evaluation (CDE) performs a technical review while the National Institutes for Food and Drug Control (NIFDC) conducts sample testing of investigational entities. Since 2015, this process has been determined by drug category, with applicants registering products in one of five categories. Priority for review and approval is given based on level of innovation and clinical need, with globally innovative drugs reviewed first, innovative agents addressing urgent clinical need considered second, and generics after that.
Other recently implemented reforms also aim to streamline the registration process and include a one-time approval procedure for new drug clinical trial applications (formerly, new approvals were needed for each clinical trial phase). Submission of research results and the next-phase clinical trial protocol to the CDE after completion of Phase I and II studies is all that is required to move to the next clinical trial phase (provided no safety issues have arisen). For generics, the previous full review and approval process has been cancelled and proposed bioequivalence studies need only be filed with the CFDA after EC approval and a clinical site agreement has been signed.
While an incredibly lucrative market, the long lead times and red-tape that created barriers to entry into the Chinese clinical trial space are gradually being broken down. Even so, a key requirement is for filings to be in Chinese language and submitted via a Chinese legal entity. Thus, overseas drug manufacturers must either have legal representation in China or use a local agent.
GreenLight China, based in Nanjing is uniquely placed to support your entry into the Chinese marketplace. With a team of Chinese language specialists in study start-up, IP import, clinical operations and regulatory affairs – we can help you break into the Chinese market quickly and efficiently.
Thailand – Coordinated, streamlined regulation
Thailand has a 20-year history of globally sponsored clinical trials, supported by an established regime of GCP (since 2000), modern medical facilities and a cadre of qualified and well-trained health professionals. These factors plus active support for clinical trials from government and clinicians have seen a streamlined regulatory process develop.
However, by virtue of its role controlling research drug importation, the Thai Food and Drug Administration (T-FDA) indirectly regulates drug clinical trials in humans. Working under the Ministry of Public Health (MOPH), the T-FDA is more broadly authorised to ensure the quality, safety and efficacy of drugs, medical devices, cosmetics and foods.
The T-FDA’s scope of assessment covers all clinical trial phases and a range of drug categories, including new, traditional and locally-produced or imported drugs. Approval of a drug importation permit is dependent upon proven EC approval to conduct the clinical trial by a T-FDA approved institutional EC (of which there are 15 across Thailand).
The EC approval can be submitted to the T-FDA after the rest of the application has been lodged since the T-FDA and EC may conduct their reviews in parallel. The EC approval must be provided to the T-FDA within 14 days of reaching the decision. EC approvals are site-specific and multi-centre trials require EC review and approval for all participating institutions.
Although gradually becoming more streamlined – local knowledge, language expertise and regulatory experience is vital in to take your trial through review in a timely manner.
GreenLight Thailand, based in the center of Bangkok has a proven track record of successful study start-up, IP import and fast recruitment in the biggest hospitals in the country. With over 2000 beds and specialist outpatient centres geared for clinical trials, Thailand is the ideal place to enter the Asia Pacific, with a partner who knows and understands the region, with boots on the ground in this emerging clinical trial hot-spot.