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Nov 26, 2024
Pharmaceutical Consulting
Quick overview of expanding your Chinese medicine brand in Singapore
Are you considering bringing your Chinese medicine products to Singapore? With a clear regulatory framework, zero registration fees, and swift evaluation timelines, Singapore presents an exciting opportunity for Chinese companies aiming to expand into Southeast Asia. Let’s explore the key differences in regulations between China and Singapore—and how The Reg Consultants (TRC) can guide your seamless entry into this promising market.
China vs. Singapore: A Quick Regulatory Comparison on How Chinese Medicine is Regulated
China: National Medical Products Administration (NMPA) oversees Chinese medicine, which is mainly classified as traditional Chinese patent medicine. The regulatory process is rigorous, requiring extensive safety and efficacy data. Products with therapeutic claims must undergo clinical trials and detailed documentation reviews.
Singapore: Health Sciences Authority (HSA) regulates Chinese medicine under the Chinese Proprietary Medicine (CPM) category. This includes oral, topical, or inhaled products based on traditional principles. Unlike China, no clinical trials are needed, offering a streamlined and efficient process that maintains high safety and quality standards.
Registration Pathways and Timelines
China: For therapeutic products, the regulatory process spans multiple steps—clinical trials, lab testing, and safety assessments. Timelines often stretch from 2 to 5 years, making market entry a lengthy commitment.
Singapore: The evaluation process for CPM products is notably faster—approximately 60 working days. Better yet, there are no registration fees, making Singapore a cost-effective and accessible market for expansion.
Documentation requirements:
China: Extensive clinical, safety and GMP data
Singapore: Leverage on country of origin clinical and safety data. Data are more focused on CMC perspective.
Why Singapore is Your Gateway to Southeast Asia
1. Simplified and Cost-Effective Registration
Singapore offers a straightforward regulatory pathway with unparalleled advantages for Chinese manufacturers:
Evaluation in Just 60 Days: HSA expedites evaluations for CPM products without sacrificing quality or compliance.
Zero Registration Fees: By removing registration costs, Singapore reduces financial barriers for companies entering the market.
2. Practical Documentation Requirements
Singapore’s approach to documentation emphasizes practicality, minimizing administrative burdens for manufacturers:
Formulation and Ingredient Safety: Provide clear details about your product’s composition.
Manufacturing Standards: Submit quality control and safety protocols to meet GMP standards.
Ready to bring your Chinese medicine products to Singapore? Contact TRC today and let’s embark on this exciting journey together!
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If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!