The Asia-Pacific (APAC) region is emerging as a prime hub for clinical trials, attracting attention from pharmaceutical companies, biotechnology firms, and contract research organisations (CROs) worldwide.
The region's unique combination of diverse patient populations, cost advantages, and growing government support has made it an appealing area for clinical research.
However, navigating a complex and varied regulatory environment presents plenty of challenges. For one, APAC countries and territories each have their own regulatory frameworks governing clinical trials, which can be difficult to navigate without experience. Each has distinct requirements for trial approvals, patient consent, data privacy, and ethics review, meaning that even small regulatory differences, when managed incorrectly, can significantly impact timelines, costs, and trial feasibility.
This article aims to outline some of the key regulatory requirements and governing bodies for conducting clinical trials across the APAC region.
APAC Clinical Trials: Regulatory Requirements by Country/Territory
Given the region's diversity, it is no surprise that navigating APAC's regulatory framework can be challenging. With each nation enforcing its standards for clinical trial approvals, patient safety, data privacy, and ethical oversight, it is clear that CROs and their sponsors have a major regulatory maze to navigate
Here’s an overview of clinical trial regulatory requirements throughout APAC.
Australia
When it comes to clinical research in APAC, Australia is known for its efficient and straightforward regulatory processes, making it a preferred destination for early-phase clinical trials. With a well-established regulatory framework and supportive tax incentives, it is particularly attractive for sponsors seeking quick trial setup and lower costs.
Regulatory Authority:
Clinical Trial Approval:
Clinical Trial Notification (CTN) Scheme: In this scheme, the trial sponsor notifies the TGA of their intent to conduct a clinical trial involving 'unapproved' therapeutic goods. The Human Research Ethics Committee (HREC) is responsible for reviewing the trial protocol's scientific validity and ethical acceptability. The TGA does not evaluate any data relating to the clinical trial at the time of submission.
Clinical Trial Approval (CTA) Scheme: This scheme involves a formal evaluation process by the TGA. The sponsor submits an application seeking approval to supply 'unapproved' therapeutic goods in a clinical trial. The TGA evaluates summary information about the product, including relevant scientific data, before the start of the trial. The HREC is responsible for considering the scientific and ethical issues of the proposed trial protocol.
Key Regulations:
Strict adherence to the National Statement on Ethical Conduct in Human Research.
Compliance with the Privacy Act for handling patient data.
All regulatory documents and informed consent forms must be in English.
Average approval timeline (submission to final approval), including EC:
CTN scheme (HREC approval): 2-3 months
CTA scheme (TGA approval): 4-6 months*
China
China has become a significant hub for clinical trials, supported by its large patient population and government initiatives to streamline approvals. However, its regulatory environment remains complex, with strict ethical approvals and data localisation requirements.
Regulatory Authority:
Clinical Trial Approval:
Requires approval from an independent Ethics Committee (EC) and the NMPA before initiating a trial.
Key Regulations:
Adherence to GCP (Good Clinical Practice) and updated Drug Administration Law (2019) is required for clinical trials.
Mandatory clinical trial applications (CTAs) for investigational drugs.
All regulatory submissions, patient-facing materials, and informed consent forms must be translated into Mandarin.
Average approval timeline (submission to final approval), including EC:
6-8 months*
India
India offers significant opportunities for clinical research due to its vast patient population and growing infrastructure. Recent regulatory reforms have aimed to increase transparency and improve patient safety, making India an attractive location for biopharma companies looking to perform clinical trials.
Regulatory Authority:
Clinical Trial Approval:
Approval from the Drug Controller General of India (DCGI) and a local ethics committee is required.
Subject Expert Committees (SECs) review applications based on therapeutic areas.
Key Regulations:
Focus on patient safety with strict rules for informed consent, including audiovisual recording for certain trials.
Compensation must be provided for trial-related injuries or deaths, as per updated regulations.
Post-trial access to investigational drugs for participants is mandated under certain conditions.
Patient informed consent forms and patient-facing materials must be translated into local languages that participants understand.
Average approval timeline (submission to final approval), including EC:
3-5 months*
Indonesia
Indonesia's clinical trial sector is growing, supported by its large population and increasing government focus on healthcare research. However, the regulatory process can be time-consuming and requires meticulous attention to detail.
Regulatory Authority:
Clinical Trial Approval:
Requires approval from BPOM and a local Ethics Committee (EC).
Import permits for investigational products must be obtained separately.
Key Regulations:
Compliance with Good Clinical Practice (GCP) as defined by Indonesian guidelines.
Stringent requirements for ethical approvals and patient consent.
Patient-facing documents and consent forms must be translated into Bahasa Indonesia.
Average approval timeline (submission to final approval), including EC:
3-5 months*
Japan
Japan has one of the most well-structured regulatory environments in APAC, with a strong focus on patient safety and trial efficacy. Its requirement for local clinical trial data adds an extra layer of complexity, making local expertise crucial.
Regulatory Authority:
Clinical Trial Approval:
The PMDA offers pre-consultation services to advise CROs and their sponsors on protocol design and data requirements.
Approval from local Institutional Review Boards (IRBs) and the PMDA is mandatory.
Key Regulations:
Trials must comply with Japan's Pharmaceutical and Medical Device Act (PMD Act).
Local Clinical Trial Requirements: Data from trials conducted in Japan may be required for regulatory submission.
All documentation, including consent forms and regulatory submissions, must be in Japanese.
Average approval timeline (submission to final approval), including EC:
3-5 months*
Singapore
Singapore is recognised for its highly efficient regulatory processes and adherence to international clinical trial standards. Its reputation as a regional hub for early-phase trials is further supported by its robust healthcare infrastructure.
Regulatory Authority:
Clinical Trial Approval:
Clinical Trial Notification (CTN): Applicable for clinical trials involving lower-risk therapeutic products that are registered in Singapore and used according to their approved labelling. Sponsors are required to notify the HSA before starting the trial.
Clinical Trial Certificate (CTC): Required for clinical trials involving medicinal products that are not subject to a Clinical Trial Authorisation (CTA) or CTN requirements. Sponsors must submit a CTC application to the HSA before commencing the trial.
Clinical Trial Authorisation (CTA): Necessary for clinical trials involving therapeutic products not registered in Singapore or used in a manner inconsistent with their approved labelling. Sponsors must obtain a CTA from the HSA before initiating the trial.
Key Regulations:
Strong alignment with ICH-GCP standards for trial conduct.
Rigorous compliance with the Personal Data Protection Act (PDPA) for handling patient information.
All regulatory submissions and patient consent forms must be in English.
Efficient approval process with clear timelines, making it a preferred hub for early-phase clinical trials.
Average approval timeline (submission to final approval), including EC:
3-4 months*
Malaysia
Thanks to its supportive regulatory environment, cost-efficiency, and diverse patient pool, Malaysia is emerging as a strong destination for medical research organisations. The country's alignment with international standards and streamlined regulatory pathways make it ideal for CROs and their sponsors looking to conduct early-phase and late-phase clinical studies.
Regulatory Authority: National Pharmaceutical Regulatory Agency (NPRA).
Clinical Trial Approval:
Clinical Trial Import License (CTIL): Required for the importation of unregistered investigational medicinal products (IMPs) into Malaysia for clinical trial purposes. Sponsors must obtain a CTIL from the NPRA before any import activities begin.
Clinical Trial Exemption (CTX): Applicable when an investigational product is locally manufactured. Sponsors must secure a CTX approval from the NPRA prior to trial initiation.
Ethics Review: All clinical trials must receive approval from a registered Institutional Review Board (IRB) or an Ethics Committee (EC) in Malaysia. The ethics approval must be in place before the NPRA can issue a final clearance.
Key Regulations:
Strong adherence to ICH-GCP standards, ensuring international quality and safety benchmarks are met.
Compliance with the Malaysian Personal Data Protection Act (PDPA) for safeguarding patient information throughout the clinical trial.
Regulatory submissions, including protocols and informed consent forms and patient-facing materials, must be in English, with translations as needed for local understanding.
The parallel submission process for ethics and regulatory approval helps expedite the start of clinical trials, reducing the time to site initiation.
Average approval timeline (submission to final approval), including EC:
3-5 months*
South Korea
South Korea is a leading destination for clinical trials in Asia, driven by its strong healthcare infrastructure, government support for innovation, and high standards in regulatory processes. It is known for its rapid study initiation and access to a sophisticated patient population.
Regulatory Authority: Ministry of Food and Drug Safety (MFDS).
Clinical Trial Approval:
Investigational New Drug (IND) Application: Sponsors must submit an IND to the MFDS for clinical trials involving unregistered medicinal products or investigational use beyond current labelling. The MFDS reviews protocols to ensure compliance with safety standards.
Institutional Review Board (IRB): Clinical trials must also gain approval from an IRB, which works in parallel with MFDS reviews, helping streamline the approval timeline.
Key Regulations:
Strict adherence to ICH-GCP standards ensures the high quality of clinical trials conducted in Korea
Patient privacy is regulated under the Personal Information Protection Act (PIPA), which is among the strongest data protection regulations in the region.
Most regulatory submissions and informed consent forms and patient-facing materials are completed in Korean, ensuring clear communication with trial participants.
Average approval timeline (submission to final approval), including EC:
3-6 months*
Philippines
The Philippines offers a cost-effective environment for clinical trials, supported by an improving regulatory landscape, diverse patient demographics, and high prevalence of diseases suitable for global studies.
Regulatory Authority: Food and Drug Administration Philippines (FDA Philippines).
Clinical Trial Approval:
Clinical Trial Approval (CTA): For clinical trials conducted in the Philippines, CROs or sponsors must obtain a CTA from the FDA Philippines for any investigational product not registered in the country. The approval process ensures patient safety and product quality.
Ethics Review: All trials need approval from an accredited Institutional Review Board (IRB) before trial initiation, with simultaneous submission to streamline processes.
Key Regulations:
Compliance with ICH-GCP guidelines for conducting trials.
Patient data handling follows the Data Privacy Act of 2012, which ensures confidentiality and protection of personal information.
Regulatory submissions, including consent forms, are typically in English, making the process convenient for international sponsors.
Average approval timeline (submission to final approval), including EC:
4-6 months*
Taiwan
Taiwan is known for its efficient regulatory process, high-quality medical facilities, and government support, making it an attractive destination for clinical trials in Asia-Pacific.
Regulatory Authority: Taiwan Food and Drug Administration (TFDA).
Clinical Trial Approval:
Investigational New Drug (IND) Approval: Required for trials involving unregistered therapeutic products or investigational use outside of approved indications. Sponsors must obtain an IND from the TFDA before starting a trial.
Institutional Review Board (IRB): IRB approval is required in parallel with the TFDA review, contributing to an efficient overall process.
Key Regulations:
Strong compliance with ICH-GCP standards and international ethical guidelines.
Patient privacy is protected under the Personal Data Protection Act, which governs the use of clinical trial data.
Regulatory and ethics documents can be submitted in English with translations required for protocol synopsis; informed consent forms and patient-facing materials must be in Traditional Chinese.
Average approval timeline (submission to final approval), including EC:
4-6 months*
Hong Kong
Hong Kong is positioned as an important hub for clinical trials in Asia, particularly for early-phase studies, due to its advanced healthcare facilities and strategic location bridging Western and Chinese markets.
Regulatory Authority: Department of Health, Hong Kong.
Clinical Trial Approval:
Clinical Trial Certificate (CTC): Sponsors must apply for a CTC from the Department of Health for clinical trials involving investigational products. The application process is designed to ensure rigorous safety standards are met.
Institutional Review Board (IRB): Trials also need ethics approval from a local IRB. This approval process often works concurrently with the Department of Health’s review.
Key Regulations:
Compliance with ICH-GCP guidelines is strictly enforced.
Patient data is safeguarded under the Personal Data (Privacy) Ordinance, ensuring robust protection of participants’ personal information.
Regulatory documents are acceptable in English with informed consent forms and patient-facing materials required to be Traditional Chinese, depending on patient demographics.
Average approval timeline (submission to final approval), including EC:
3-4 months*
Thailand
Thailand offers a strong clinical trial environment supported by its efficient regulatory system, large patient population, and strategic government initiatives to position itself as a key player in regional clinical research.
Regulatory Authority: Food and Drug Administration Thailand (Thai FDA).
Clinical Trial Approval:
Clinical Trial Authorisation (CTA): The Thai FDA requires sponsors to obtain a CTA before starting clinical trials involving investigational products. This includes a thorough review of safety and ethical considerations.
Institutional Review Board (IRB): Ethics approval from an IRB is mandatory before starting any clinical trial, with the review process often conducted concurrently with the Thai FDA’s review.
Key Regulations:
Adherence to ICH-GCP guidelines ensures trials are conducted at an international standard.
Data protection regulations are enforced under the Personal Data Protection Act (PDPA), safeguarding patient information during trials.
Regulatory documents can be submitted in English with translation needed for the protocol synopsis and informed consent forms and patient-facing materials to be prepared in Thai.
Average approval timeline (submission to final approval): 3-4 months*
The Role of Clinical Research Organisations (CROs) in APAC
Given the challenges of APAC's diverse regulatory landscape, CROs have become indispensable partners in managing and conducting clinical trials across the region.
These companies offer the expertise and infrastructure to navigate each country's unique requirements. This enables pharmaceutical and biotech sponsors to conduct trials more efficiently and in full compliance with local laws.
By acting as intermediaries, CROs can easily coordinate with regulatory authorities, streamline ethics approvals, and ensure data compliance. Allowing them to effectively bridge the gap between global companies and local regulations.
In addition to managing regulatory complexity, CROs provide comprehensive project management services tailored to APAC's specific needs. This includes recruiting and retaining diverse patient populations, overseeing site monitoring, and handling data collection and biostatistics with precision.
Closing Thoughts
Asia-Pacific represents a dynamic and highly attractive hub for clinical trials, offering unmatched opportunities for pharmaceutical and biotech companies to access diverse patient populations and benefit from cost efficiencies.
With our unique expertise in regional regulatory navigation, project management, and experience and adherence to international quality standards, ClinActis enables sponsors to focus on their core scientific goals. By providing end-to-end support — from securing approvals to ensuring ethical and data compliance — ClinActis helps to streamline clinical trial operations and enhance the feasibility of conducting research in the region.
At ClinActis, we offer tailored solutions for pharmaceutical and biotech companies looking to conduct clinical trials across APAC. To learn more about how ClinActis can serve your business, check out our list of services here.
*Average approval timeline indicates time from initial RA/EC submission to final approval. Does not include time required for document preparation.