Your Regulatory Services Partner for Success in Singapore
Greetings from
Pharma Wizard Singapore
Thanks to its strategic location in Asia, Singapore offers immense growth opportunities for manufacturers of Medical Devices, Pharmaceuticals, Cosmetics, and Food Supplements. Regulatory oversight is managed by the Health Sciences Authority (HSA) under the Ministry of Health (MOH). While Singapore is known for its industry-friendly regulatory environment, the evolving frameworks and complex registration and licensing procedures can present significant challenges for manufacturers aiming to stay compliant.
As a trusted global regulatory partner, Pharma Wizard helps you prepare essential regulatory documents and submit applications to the relevant Singaporean authorities. Our expert Regulatory Affairs (RA) team offers end-to-end guidance to help you navigate the system efficiently, achieve product registrations, and secure approvals within short timelinesāall in a cost-effective manner.
Industries We Serve in Singapore
Medicinal Products
Medical Devices
Cosmetics
Food Supplements
Chemicals
Medicinal Product Regulatory Support in Singapore
With an advanced healthcare system, Singapore is regarded as a key drug market by renowned global pharmaceutical companies. Medicinal products in Singapore are regulated by the Health Science Authority (HSA) under Health Products Act 2007, and they must obtain necessary approvals to be distributed and marketed in the country. For innovator products, a New Drug Application (NDA) should be filed and for generic drugs, it should be a Generic Drug Application (GDA) application. All applications to the HSA must be filed or submitted through the System for Products And Registrations (SPAR). Right from compiling dossiers as per pre-defined formats, assessing ingredient limits to handling submissions through established systems, new market entrants may find it difficult to navigate the countryās Regulatory procedures.
Cosmetics play an important role in enhancing oneās inherent beauty and physical features. People are increasingly using cosmetics in their daily routine, including various types of fragrances and deodorants. This growing demand for cosmetic products has, in turn, led to the growth of the cosmetics market across the world.
In Singapore, food and supplements fall under the purview of the Singapore Food Agency (SFA). The import and sale of these products in Singapore are governed by the Sale of Food Act and the Singapore Food Regulations. Importers must ensure that their products comply with the Singapore Food Regulations and labeling requirements as per the SFA guidelines. Meanwhile, medicinal and other health-related products are regulated under the Health Sciences Authority (HSA) regulations; including Western medicinal products, Chinese proprietary medicines, and cosmetic products.
Handling chemical products to minimize the risk to human beings and the environment is challenging. Many countries, including Singapore, incorporate complex Regulatory processes to adhere right assessments for potential hazards in the chemical products for humans and the environment during production, processing, and distribution. In such scenarios, manufacturers must consider the GHS framework and information on various country-specific approaches for the risk management of chemical products