Taiwan, with its growing pharmaceutical market, is an attractive destination for drug manufacturers looking to introduce their products. However, the Taiwan FDA product registration process for pharmaceuticals is both stringent and highly regulated. This blog provides a comprehensive guide to drug registration Taiwan, helping you understand the key steps and requirements for a successful market entry.
The Taiwan Food and Drug Administration (TFDA) is the central Taiwan drug regulatory authority responsible for overseeing the registration and drug regulations in Taiwan. All pharmaceuticals must comply with the regulations and Taiwan drug registration guidelines set forth by the Taiwan drug regulatory authority, TFDA, to ensure safety, efficacy, and quality for the Taiwanese market.
Classification of Pharmaceutical Products
One of the initial steps in the Taiwan FDA Product registration process is the classification of the pharmaceutical product. The Taiwan drug regulatory authority, TFDA, classifies drugs into various categories based on factors such as the level of risk and the intended use. These classifications determine the specific requirements and documentation necessary for the Taiwan FDA Product registration process. Depending on whether your product is a new drug or a generic version of an existing one, you will follow one of two application paths. New Drug Applications (NDAs) involve more comprehensive data requirements, including preclinical and clinical studies. Generic Drug Applications require comparative bioavailability studies to demonstrate that the generic drug is equivalent to the reference product.
New Drugs and New Drug Application (NDA) in Taiwan
Taiwan drug registration guidelines defines "new drugs" as those with new chemical entities (NCE), new therapeutic compounds, or new administration routes recognized by the central competent health authority. They must undergo registration and market approval. These new drug classifications encompass various categories, including NCE, new administration routes, new therapeutic compounds, and more.
Applicants must submit an NDA application with specific documents including Form A and Form B, the NDA and BLA Refuse to File (RTF) checklist, and documents in compliance with the Regulations for Registration of Medicinal Products and its relevant appendices. The specific documents required may vary based on the category of the new drug. Prior to NDA submission, applicants have the option to apply for a Pre-NDA Meeting, Regulatory Consultation Services, or a Module-Based Rolling Review to gain a better understanding of NDA registration requirements. Submissions can be made in PDF format in CTD specifications or through the electronic dossier using the TFDA eCTD Builder.
To expedite access to life-saving drugs, Taiwan's TFDA has established five expedited programs: Abbreviated Review, Priority Review, Accelerated Approval, Breakthrough Therapy, and Paediatric and Rare Severe Disease Priority Review Voucher Program. Each program has specific criteria and review times, offering an accelerated pathway for drugs addressing critical medical needs.
The review process for NDA Taiwan follows different timelines based on the type of drug. New chemical entities (NCE) and biological products typically undergo a standard review of 360 days, while non-NCE drugs with clinical efficacy and safety data face a 300-day review. Non-NCE drugs without clinical efficacy and safety data have a 200-day review period. Extensions and inquiries can be made in certain circumstances to ensure a smooth process.
Abbreviated New Drug Applications (ANDA) in Taiwan
The classification of generic drugs in Taiwan is based on the presence or absence of the active ingredient in the medicine on the list of post-marketing surveillance. The two categories are as follows:
Generic drugs with active ingredients on the list of post-marketing surveillance.
Generic drugs with active ingredients not on the list of post-marketing surveillance.
Understanding the classification as per Taiwan drug registration guidelines is essential to determine the appropriate registration process and associated requirements.
The application fees for ANDA Taiwan are determined by the latest Standards of Review Fees for the Registration of Western Medicines and Medical Devices, issued by the Ministry of Health and Welfare. The fees depend on whether the active ingredient in the generic drug is on the list of post-marketing surveillance:
Active ingredient on the list of post-marketing surveillance: TWD 80,000.
Active ingredient not on the list of post-marketing surveillance: TWD 50,000.
These fees are a crucial consideration for pharmaceutical manufacturers seeking to register generic drugs in Taiwan.
Applicants have the option to submit requests for pre-ANDA meetings to discuss the format and content of the submitted documents. This proactive step allows for clarity and alignment with the regulatory expectations, ensuring a smoother application process. For further details, applicants can refer to the Chinese version web page or contact relevant entities like the subsidiary of the company, the local agent, or a Contract Research Organization (CRO). The review process for ANDAs involves specific timelines and procedures. It is essential to be aware of the following key points:
Supplements or amendments for deficiencies should be submitted within two months after receiving the deficiency notice. In cases where two months are insufficient, applicants can request an extension of up to one month from the final date of resubmission with an application form, limited to one application.
Applicants can submit requests for consultation via the provided platform if they have concerns regarding deficiencies. The status of the review can be tracked and monitored through the official websites of the Center for Drug Evaluation Taiwan (CDE) and the Taiwan Food and Drug Administration (TFDA).
Taiwan Agent Requirement
Drug manufacturers without a local office in Taiwan must appoint an in-country regulatory representative or Taiwan Agent. The agent plays a crucial role in facilitating communication with the TFDA and ensuring compliance with local regulations.
Quality System Requirements
In the realm of pharmaceuticals, the establishment of good manufacturing practices, encompassing manufacturing, processing, re-packaging, packaging, storage, and distribution of Western medicinal products, will draw its guidance and reference from the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Submission of Application
After compiling all required documentation, including preclinical, clinical, and quality data, you can submit your application to the TFDA. This submission will undergo a rigorous review process, during which the Center for Drug Evaluation Taiwan may request additional information or clarification.
Review and Approval
The Center for Drug Evaluation Taiwan will meticulously assess your application, reviewing the safety, efficacy, and quality of the drug. Once the review is complete, and the TFDA is satisfied with the provided data, they will issue the drug registration approval. This approval grants the right to market and sell the drug in Taiwan.
The responsibility doesn't end with registration approval. Pharmaceutical companies must continue to meet post-market surveillance and reporting requirements to ensure the ongoing safety and efficacy of their products in the Taiwanese market.
Navigating the drug registration process in Taiwan can be complex, but it's a crucial step for pharmaceutical manufacturers looking to tap into this growing market. Understanding the regulatory framework, classification of your product, and the role of a Taiwan Agent are key aspects of success. Compliance with quality system requirements and a thorough submission of the application are vital for a smooth approval process. Keep in mind that post-market surveillance is an ongoing responsibility. Partnering with experienced regulatory consultants familiar with the intricacies of the TFDA's requirements can greatly ease the process, ensuring a successful and efficient drug registration journey in Taiwan.
Navigating drug registration in Taiwan is undoubtedly challenging, but with the right guidance and expertise, it can be a manageable process. Artixio, a leading regulatory consulting firm, specializes in helping pharmaceutical companies successfully register their products in Taiwan. If you're considering entering the Taiwanese pharmaceutical market or need assistance with drug registration, contact Artixio today for expert guidance and support.
Don't hesitate to reach out to Artixio's team of professionals, who are well-versed in the intricacies of Taiwan's regulatory landscape. They can provide tailored solutions and valuable insights to streamline your drug registration process and ensure compliance with the TFDA's requirements. Artixio is your partner in making your pharmaceutical venture in Taiwan a success.
Contact Artixio now to get started on your journey to pharmaceutical market success in Taiwan. Your success is just a message or call away!