Life Science Compliance Services in Taiwan

Taiwan regulatory compliance services for life sciences firms—practical guidance from submission to successful approval. Turn your concept into commercialization with our end-to-end streamlined regulatory services.

Taiwan

Our Services

Our Countries

Our Industries

Your Partner for End-to-End Regulatory Support in Taiwan

We support companies across the life sciences sector with practical regulatory solutions tailored to every stage of the product journey. From development to registration and market entry, Artixio helps simplify the process and reduce delays. If you’re looking to fast-track approvals without cutting corners, we’re here to help.

Regulatory Authorities in Taiwan

You’ll find that in Taiwan, different health products are regulated by specific authorities. Most human health products—like medicines, medical devices, cosmetics, biologics, and food—fall under the Taiwan Food and Drug Administration (TFDA), which works under the Ministry of Health and Welfare. If you’re dealing with veterinary products, those are looked after by the Animal Health Inspection Division under the Ministry of Agriculture.

TFDA wasn’t always a single body. It was formed in 2010 by bringing together four separate units that used to handle pharmaceutical affairs, food safety, drug analysis, and controlled substances. By combining these, the government aimed to streamline oversight and make sure that both human and animal health products meet safety and quality expectations before reaching people or animals.

How We Help Meet Compliance Standards in Taiwan

Artixio is an ISO 9001:2015 certified company that provides quality and reliable services to our clients. We have region-based experts with 15-35 years of experience in guiding our clients through Pharmaceutical, Medtech, Beauty and Wellness, Food and in Animal health & Welfare sectors. Even Though we are still expanding our network and services across the globe, we have a well-established network in Taiwan. Our local Subject Matter Experts have produced a 95% of success rate for all the projects with their well-versed regulatory knowledge.

Where does our expertise come from?

With major adulteration and problems rising with substandard products, it is required by the health authorities to revise and form stringent laws and guidelines for market entry. Staying abreast of the rapidly evolving regulations is very crucial and Artixio’s expert professionals manage it well. Our expertise comes from uncompromised regulatory compliance, tech assisted regulatory intelligence services, strategized, clear, direct solution structuring, accurately executing the solutions, and regulatory gap assessment. We guide you through product development, product registration, post market entry services and product lifecycle management as well.

Post-registration

Market entry services, Post market Surveillance, Product lifecycle management services, performance evaluation reports, Advertisement and promotional material review, Digital marketing and other ongoing support services.

Services through all phases

Regulatory solutions and strategies, Response to regulatory queries, Market access, Gap assessment, Pharmacovigilance, Quality services.

Registration

Product registration (IND, NDA), Artwork and labeling, Publishing and submission services, Taiwan Agent and TFDA liaison services, testing, TFDA audit support, product approval services, and all other registration associated services.

Pre-registration

Market research, Regulatory intelligence and strategy, Technical due diligence, Product development services, Technical and medical writing and other pre-registration services.

Our Services

Why Artixio As Your Taiwan Regulatory Consultant?

FAQs

What are some common challenges faced by foreign manufacturers in Taiwan?

TFDA has put in place strict regulatory standards to guarantee the safety and quality of any product reaching the Taiwan market. TFDA demands strict regulatory compliance to these regulations as well which is a challenge. Understanding the local market, language and cultural barrier, navigating through Taiwan specific quality standards, management of the product supply chain and competence with already established brands in Taiwan are some of the other challenges faced by manufacturers in Taiwan.

What is the RTF procedure?

The Taiwanese government introduced the Refusal to File (RTF) procedure in 2017 to avoid the unnecessary review of dossiers submitted that were incomplete. Since 2017, applications that are not in CTD format, incomplete administrative or technical documents are subjected to Refusal to File decision. The applicants themselves can evaluate their application by the RTF checklists announced by TFDA. Within 14 days after submission, a decision for RTF or non-RTF is made.

What is the function of TFDA?

Product registration and examination record keeping, audit and certificate issue, manufacturers chain monitoring and correlated training, product of laboratory testing, research and technological development, product of risk assessment and management, product monitoring outbreaks investigation and resolution and promotion of consumer protection are the functions carried out by TFDA.

What are the criteria for an application to undergo priority review under TFDA?

For an application to undergo priority review process, it must meet any 2 of the following criteria: i) It must be new chemical entity, combination, indication or must have a new administration route, ii) Must meet the unmet medical needs (in the treatment of serious conditions) and should have a significant clinical advance if approved, iii) Addresses an unmet medical need and is under the special national scientific research and development programs.

What is PIC/S and is TFDA a member of PIC/S?

PIC/S, the Pharmaceutical Inspection Co-operation Scheme is an international official organization which consists of 49 participating authorities in the GMP field of medicinal products from all over the world. It focuses on the developing, implementing and maintaining harmonized GMP standards and quality system of inspectators globally and other international affairs as well. Yes, TFDA is a member of PIC/S.

Life Science Compliance Services in Taiwan

Taiwan

Our Services

Our Countries

Our Industries

Your Partner for End-to-End Regulatory Support in Taiwan

Regulatory Authorities in Taiwan

How We Help Meet Compliance Standards in Taiwan

Where does our expertise come from?

Post-registration

Services through all phases

Registration

Pre-registration

Our Services

Why Artixio As Your Taiwan Regulatory Consultant?

FAQs

What are some common challenges faced by foreign manufacturers in Taiwan?

What is the RTF procedure?

What is the function of TFDA?

What are the criteria for an application to undergo priority review under TFDA?

What is PIC/S and is TFDA a member of PIC/S?

Industries We Serve in Taiwan

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

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