Market entry guide for China pharmaceutical companies to enter Singapore


Entering a new market like Singapore can indeed be a strategic move for Chinese pharmaceutical companies expanding into Southeast Asia. Today TRC would like to highlight 6 key areas from a regulatory perspective:

1. Quality of the CMC documents- Drug Substance

a)     GMP Compliance: Starting from October 2024, compliance with Good Manufacturing Practice (GMP) regulations will be necessary for drug substance manufacturers in Singapore. This requires either a valid GMP certificate issued by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) authority or a Certificate of Suitability and valid Active Pharmaceutical Ingredient (API) registration certificate covering the drug substance of interest listed on the European Union Drug Regulatory Authorities (EURDRA) GMP. Without these documents, product registration in Singapore will not be possible.

b)    Specifications: Specifications and limits  for the drug substance must be established in accordance to validated analytical methodology and based on understanding of the manufacturing process and data collected from the course of stability studies, stress testing and process validation . Reference to ICHQ2 and Q6A will be appropriate. The drug product manufacturer should have final control over the quality of the drug substance incorporated into the final formulation. Therefore, the drug product manufacturer should maintain  a final controlled version of the drug substance specifications.

c)     Process Validation: Process validation data should be submitted in accordance with the requirements outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M4Q guidelines.

d)    Stability Studies: Stability data from at least three primary batches, two pilot batches, or one small-scale batch should be submitted from the drug substance manufacturer based on ICH Q1 requirements. If the drug substance is sourced from multiple sites, stability data from each site should be provided. Additionally, stress testing data should be submitted to assess the stability of the drug substance under various conditions.

 2. Quality of the CMC documents- Drug Product

a)  Certificate of Pharmaceutical Product (CPP) –Proof of approval should be in World Health Organization (WHO) format and issued from the country of origin or the country where the product owner/manufacturer is based. If the CPP indicates that the product is not marketed, it will not be accepted.

b)    GMP Compliance- The drug product (DP) manufacturing site should have valid proof of Good Manufacturing Practice (GMP) compliance at the time of submission. Singapore follows the standards of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines. The manufacturing site should evaluate compliance with PIC/S standards. For more information, you may check out this article: https://theregconsultants.com/registering-an-overseas-manufacturing-site-in-singapore-for-pharmaceutical-products/

c)    Specifications of the Drug Product – Specifications and limits for the drug product should be established and conducted based on validated analytical procedures in accordance with ICH Q2 and ICH Q6A guidelines. These specifications govern the release and stability of the drug product which impacts on the safety and quality of the drug product.

d)    Process Validation – Process validation data requirements depend on the type of dosage form, including solid oral drug products, aseptically processed drug products, and terminally sterilized drug products. Submission should include data from three consecutive manufactured batches according to the proposed manufacturing process and batch size.

e)     Stability-  Stability studies should cover data specified for Zone IVb (30°C/75%RH) and include data from three primary batches of 12 months for critical dosage form such as injectables  and two primary batches of  6 months for conventional dosage form such as tablets and capsules . Studies should be conducted according to the proposed batch size, strength, and container closure system intended for marketing in Singapore.

3. Clinical efficacy

a) Acceptance of Foreign Clinical Trial Data –Most ASEAN countries, including Singapore, accept foreign clinical trial data. This means that data generated from clinical trials conducted outside of Singapore can be used to support product registration in these countries as long as they are conducted in accordance to GCP guidelines and relevant ICH guidelines.

b)Phase III Confirmatory Trials –To support each requested indication and dosing regimen for the product being registered,  data from Phase III trials, which are confirmatory, randomized, controlled pivotal trials, compliance with Good Clinical Practice (GCP) guidelines is required.

c) Bridging Studies/Comparative Studies –In the case of biosimilars and generics, bridging studies or comparative studies may be required. These studies aim to demonstrate that the biosimilar or generic product is comparable to the reference product in terms of pharmacokinetic (PK) and pharmacodynamic (PD) parameters. The goal is to show that there are no significant differences between the test product and the reference product in terms of safety and efficacy.

    5.Language Barrier-  Dossier written in  simplified Mandarin should be translated and verified in a way that the content reflects what is written in the original language and official documentation such as Proof of GMP, approval letters should be authenticated by the foreign embassy or consulate of the country of origin. 

    6. Marketing Authorization RequirementsIn Singapore, only a local registered entity can hold the marketing authorization for pharmaceutical products. This means that companies seeking to market their products in Singapore must either establish their own legal entity in Singapore or engage a consultant who operates locally.

    The MAH is responsible for ensuring compliance with regulatory requirements throughout the lifecycle of the product. This includes responsibilities such as product registration, pharmacovigilance, labeling and advertising compliance, and maintaining a quality management system.

    To learn more about the responsibilities of a MAH, please visit: https://theregconsultants.com/responsibilities-of-a-marketing-authorization-holder-mah/

    With that we have concluded key areas to evaluate prior to entering the Singapore market, if you need help and support to evaluate your dossier for registration in Singapore, please feel free to get in touch: https://theregconsultants.com/contact-us/

     

     

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