NEWS & EVENTS
Conducting clinical trials in china and thailand
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.
Asian countries offer great market potential and value
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.