Misconception of regulatory classification of medical products

Registration of a medical product starts with an official classification which will determine the documentary requirements, timelines, and fees. Today we are going to share a few misconceptions and the approach to classify a product correctly. Misconception We assume that the classification in the country of origin will be the classification in the country to […]

05 Sep 2023 |
Market Entry & Regulatory Strategy

The Role of Regulatory Affairs Management in International Expansion for Pharma Companies

As pharmaceutical companies worldwide continue to expand their global reach, navigating the intricate landscape of international markets becomes an increasingly complex endeavour. In this era of heightened regulatory scrutiny, pharma companies must be well-versed in the multifaceted world of regulatory affairs in order to successfully expand their operations beyond borders. We’ll explore the indispensable role […]

30 Aug 2023 |
Market Entry & Regulatory Strategy

Quick overview of biosimilar registration in Singapore

What is a biosimilar? A biosimilar product is a biological therapeutic product demonstrated to be similar, in physicochemical characteristics, biological activity, safety and efficacy to an existing registered biological product. The development of a biosimilar product places emphasis on the characterization of the reference’s Quality Target Product Profile and performing comparability and safety studies to […]

29 Aug 2023 |
Pharmaceuticals

Overcoming the challenges of a generic drug application and registration in Singapore

A generic product must have the same qualitative and quantitative composition in active ingredients and be of the same pharmaceutical form as a currently registered product in Singapore and shown to be bioequivalent to Singapore Reference Product (SRP). A marketing authorization application for a generic product fall under the application category of GDA-1 and GDA-2 […]

22 Aug 2023 |
Pharmaceuticals

A bottle of radiopharmaceutical product.

Registration of a radiopharmaceutical product in Singapore

A radiopharmaceutical drug is defined as a radioactive pharmaceutical agent that is used for diagnostic or therapeutic procedures. A radiopharmaceutical consists of a drug component and a radioactive component. Current registered radiopharmaceutical product in Singapore includes but not limited to : Sodium pertechnetate (99mTc), Sodium Molybdate(99Mo), RADIUM-223 CHLORIDE, Sodium Iodide [I-131] . Just like […]

08 Aug 2023 |
Pharmaceuticals

Responsibilities of a Marketing Authorization Holder (MAH)

A Marketing Authorization Holder (MAH) is a local company that is assigned by the Manufacturer to be in charge of all licensing matters.

31 Jul 2023 |
Market Entry & Regulatory Strategy

News & Articles

Recent Posts

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!