REGULATION TO ESTABLISH PHARMACEUTICAL COMPANY IN SINGAPORE

Setting up a pharmaceutical company in Singapore is an attractive prospect for investors due to the country's robust regulatory framework and strategic location. This article explores how to establish pharmaceutical company in Singapore and goes through the industry's potential, key regulations, and the various types of pharmaceutical entities in the country.

Overview to establish pharmaceutical company in Singapore

Singapore’s pharmaceutical industry has grown significantly, presenting opportunities for both local and foreign investors. Before starting operations, understanding the regulatory requirements and the industry's potential is crucial.

Growth potential of Singapore's pharmaceutical industry for investors

Singapore’s pharmaceutical sector is projected to continue its rapid growth in 2025, driven by its advanced infrastructure and strategic government initiatives. As a hub for biotechnology and pharmaceutical companies, Singapore offers a conducive environment for research and development. Foreign investors benefit from tax incentives, research grants, and an efficient regulatory process. The country’s commitment to innovation ensures sustained industry growth, making it a prime destination for investment in the pharmaceutical sector. Additionally, Singapore’s stable political environment and its strong intellectual property protection further bolster investor confidence. With rising global demand for healthcare solutions, Singapore’s pharmaceutical industry remains a lucrative market for foreign entities.

Singapore’s location and efficient regulations offer foreign investors many opportunities

Pharmaceutical regulations in Singapore

All pharmaceutical companies in Singapore must adhere to strict regulatory requirements to ensure safety and quality. Companies must obtain a product license before exporting or selling any pharmaceutical products. The Singapore Health Sciences Authority (HSA) oversees the application process, which requires submissions in either the ASEAN Common Technical Document (ACTD) format or the International Conference on Harmonization (ICH) Common Technical Document (CTD) format. These licenses cater to both generic and new drug applications, ensuring compliance with international standards. Companies must also conduct rigorous quality testing to meet local and global requirements. Strict adherence to these regulations ensures that Singapore maintains its reputation for producing high-quality pharmaceutical products. Failure to comply with these rules may result in penalties or license revocation.

Types of pharmaceutical entities in Singapore

Understanding the types of pharmaceutical companies in Singapore helps entrepreneurs decide the appropriate business model. Each type has distinct requirements and operational guidelines.

The registration of medicinal products in Singapore

Before obtaining operational licenses, founders must register their company with the Singapore Trade Register. Medicinal products intended for manufacture or sale must be registered with the HSA. The Medicines Act in Singapore defines a medicinal product as a substance administered to humans for therapeutic purposes or used to prevent or treat diseases. The product license is issued for specific products with defined compositions, dosages, and usage indications. Singapore categorizes pharmaceutical products into three forensic classes: Prescription Only Medicine (POM), Pharmacy Only Medicine (P), and General Sale List Medicine (GSL). Proper categorization and adherence to licensing ensure that pharmaceutical companies meet safety and efficacy standards. This systematic approach helps maintain public trust and industry integrity.

Adhering to proper product licensing ensures quality to successfully establish pharmaceutical company in Singapore

Setting up retail pharmacies in Singapore

Foreign investors may establish retail pharmacies in Singapore, which are subject to less stringent requirements compared to manufacturing companies. These pharmacies can sell over-the-counter drugs without requiring prescriptions but must still gain HSA approval. Retail pharmacies are allowed to sell therapeutic products, oral dental gums, and pharmaceutical items on the General Sale List. However, all products must be dispensed by licensed pharmacists. Before receiving an operational license, the pharmacy must pass inspections and audits conducted by the HSA. Licenses required for retail pharmacies include wholesale retailer permits and import/export permits. Additionally, a healthcare institution license is mandatory to comply with operational regulations.

Registration of pharmacists in Singapore

Pharmacies in Singapore must hire registered pharmacists to manage operations and ensure compliance with healthcare standards. The Singapore Pharmacy Council oversees the registration of pharmacists, including both local and foreign professionals. Foreign pharmacists must have their qualifications recognized by the Council to obtain a Practicing Certificate. This ensures that all personnel involved in dispensing medicines meet stringent professional requirements, maintaining high standards of care. Singapore’s emphasis on hiring qualified professionals reflects its commitment to healthcare excellence. This requirement ensures the safe handling and distribution of pharmaceutical products. With G2B, you can streamline your setup process and focus on your core business activities. Our dedicated team is here to help you with all your needs. G2B services provide professional and reliable support, guiding businesses through proper company establishment and annual compliance, opening local/ digital bank accounts, ensuring smooth operations and minimizing legal risks from the outset.

The registration of pharmacists guarantees high standards in Singapore’s pharmaceutical industry

Understanding the potential of the pharmaceutical sector, coupled with the clear categorization of medicinal products and operational licenses, provides a solid foundation to establish pharmaceutical company in Singapore. Whether setting up a manufacturing unit, a retail pharmacy, or hiring skilled pharmacists, Singapore’s streamlined processes and supportive ecosystem make it an ideal destination for growth in the pharmaceutical industry. For more information on business registration in Singapore, contact G2B today to receive comprehensive consulting based on your situation! Let G2B be your trusted partner, guiding you through every stage of Singapore business registration with reliability and dedication.