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This application is a service of the Singapore Government.

Frequently Asked Questions

Health Products Regulation

Therapeutic Products > Therapeutic Product Registration > Registering a Generic TP

1.
How do I determine the Singapore Reference Product (SRP) for my generic application?

A SRP can be identified using the searchable Register of Therapeutic Products on the HSA website. In situations where a SRP could not be identified, such as where a corresponding registered product of the same strength is absent and the applicant is proposing an alternative reference product, the applicant should contact HSA at HSA_TP_Enquiry@hsa.gov.sg for further advice. In these instances, the applicant should provide scientific justification to substantiate the basis of using an alternative reference product.

Applicants should also note that the use of a registered product of lower strength as the reference product for a generic drug of a higher strength is not acceptable. 

2.
Can I submit generic drug applications for multiple strengths of a generic drug using a single strength bioequivalence (BE) study?

When a generic product is to be marketed in several strengths, the results of a single BE study may be extrapolated to all strengths if the following criteria are fulfilled :

  1. the different strengths of the generic product are manufactured by the same manufacturing process;
  2. the qualitative composition of the different strengths is the same;
  3. the composition of the strengths are quantitatively proportional, i.e. the ratio between the amount of each excipient to the amount of active substance(s) is the same for all strengths (for immediate release products, coating components, capsule shell, colour agents and flavours are not required to follow this rule);

    If there is some deviation from the quantitatively proportional composition, condition (c) is still considered fulfilled if condition (i) and (ii) or (i) and (iii) below apply to the strength used in the bioequivalence study and the strength(s) for which a waiver is considered:

    1. the amount of the active substance(s) is less than 5 % of the tablet core weight or the weight of the capsule content;
    2. the amounts of the different core excipients or capsule content are the same for the concerned strengths and only the amount of active substance is changed;
    3. the amount of a filler is changed to account for the change in amount of active substance. The amounts of other core excipients or capsule content should be the same for the concerned strengths.
  4. appropriate comparative dissolution profile testing
  5. Demonstration of pharmacokinetic linearity of the active ingredient(s) over the therapeutic dose range in accordance with international guidelines, e.g. ASEAN, EU CHMP.

3.
What are the criteria for qualifying for Verification-CECA route?

The Verification-CECA route is implemented under the Comprehensive Economic Cooperation Agreement (CECA) between India and Singapore to facilitate market entry of India-manufactured generic products into Singapore.

Generic drugs  eligible for registration under the Verification-CECA route must meet the following criteria:
a)     Must be manufactured at a licensed manufacturing facility in India;
b)     The product must be approved by at least one of HSA’s reference agencies (US FDA, EMA, UK MHRA, Australia TGA and Health Canada) within two years from the date of submission to HSA;  and,
c)     All aspects of the generic product's quality, including formulation, manufacturing site(s), specifications and primary packaging, must be identical to that approved by the reference agency.

4.
Does the data protection period start from the point of receipt of an application or grant of registration by HSA?

The Health Products (Therapeutic Products) Regulations provide for protection of confidential supporting information as well as protection of safety and efficacy data, under Regulation 26 and Regulation 29  respectively. Whether or not the protection applies depends on whether the therapeutic product application fulfils the specified conditions.

Regulation 26 provides for protection of confidential supporting information relating to an innovative therapeutic product application for a period of 5 years, from the date that application is received by the Authority.

Regulation 29 provides for exclusivity of safety and efficacy data for a period of 5 years from the date of registration of the therapeutic product.  Relevant information on Product Registration, including the date of grant of registration, can be obtained from the Register of Therapeutic Products available on the HSA website.

 

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