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Opening a Pharmaceutical Company in Singapore

Updated on Thursday 19th May 2016

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Opening-a-Pharmaceutical-Company-in-SingaporeThe Singapore pharmaceutical market

Singapore has become an important hub for pharmaceutical research and manufacturing companies during the last few years. Some of the greatest pharmaceutical companies in the world have an established presence in Singapore due to the clear regulatory environment. Singapore’s health system ranked 6th in the World Health Organization’s report for 2013.  The main factors contributing to the development of the pharmaceuticals industry were the developed infrastructure and logistics network and the Government’s support for biomedical companies in Singapore.

Pharmaceutical regulations and approvals in Singapore

All drug companies in Singapore are required to obtain a product license before exporting or selling pharmaceutical products. The product license application must be submitted with the Singapore Health Sciences Authority (HSA) and must have the Association of Southeast Asian Nations (ASEAN) Common Technical Document format or the Common Technical Document (CTD) format designed by the International Conference on Harmonization (ICH). Companies may obtain both generic drug licenses and new drug licenses in Singapore.

The registration of medicinal products in Singapore

Before obtaining all necessary permits and licenses, founders must register the company with the Singapore Trade Register. After the registration procedure our experts in Singapore may help you with, the medicinal products to be manufactured or sold must be registered with the HSA. According to the Medicines Act in Singapore, a medicinal product is any substance or article with the following characteristics:

  • - will be administered to humans for medicinal purpose,
  • - uses ingredients used for medicinal purposes,
  • - treats or prevents diseases.

The product license is required before the Singapore pharmaceutical company starts operating and may be issued for a single product only. The product license is issued:

  • - for a product using a specific name,
  • - with a certain composition,
  • - with a particular dosage,
  • - with specific indications for use.

All pharmaceutical products produced or sold by Singapore companies fall under the following forensic classes:

  • - prescription only medicine (POM),
  • - pharmacy only medicine (P),
  • - general sale list medicine (GSL).

For information about the legislation on medicinal product registration please contact our specialists in company incorporation in Singapore.

 

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