The Health Products Regulation Group (HPRG) safeguards public health by ensuring that medicinal and health-related products in Singapore meet appropriate standards of safety, quality and efficacy.
HPRG carries out pre-marketing evaluation of medicinal products before they are allowed to be marketed in Singapore. Products currently regulated include western medicinal products, Chinese proprietary medicines and cosmetic products. The regulatory framework for health supplements is being developed. HPRG is also responsible for the regulation of clinical trials in Singapore and the provision of unbiased drug information to health professionals and the public. In addition, the Centre administers and enforces the Smoking (Control of Advertisements and Sale of Tobacco) Act in support of the Government's efforts to reduce smoking and promote public health.
HPRG regulates medicinal and other health-related products under the Medicines Act, the Poisons Act, the Sale of Drugs Act, the Medicines (Advertisement and Sale) Act and the Misuse of Drug Regulations. Post-marketing regulatory activities include quality surveillance programmes, routine inspections and investigations into contraventions of legislation. When necessary, legal action is taken against the offenders by way of compounding or prosecution in court.
The spontaneous reporting of adverse drug reactions by doctors and other health professionals is also one of the important tools used by HPRG to keep continued vigilance on the safety of all marketed drugs in Singapore.
In addition, HPRG inspects and licenses pharmaceutical manufacturers and importers/wholesale dealers in accordance with current international Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards respectively. This ensures the production of good quality medicines and preservation of their quality down the supply chain from the manufacturers to distributors and retailers.
HPRG carries out pre-marketing evaluation of medicinal products before they are allowed to be marketed in Singapore. Products currently regulated include western medicinal products, Chinese proprietary medicines and cosmetic products. The regulatory framework for health supplements is being developed. HPRG is also responsible for the regulation of clinical trials in Singapore and the provision of unbiased drug information to health professionals and the public. In addition, the Centre administers and enforces the Smoking (Control of Advertisements and Sale of Tobacco) Act in support of the Government's efforts to reduce smoking and promote public health.
HPRG regulates medicinal and other health-related products under the Medicines Act, the Poisons Act, the Sale of Drugs Act, the Medicines (Advertisement and Sale) Act and the Misuse of Drug Regulations. Post-marketing regulatory activities include quality surveillance programmes, routine inspections and investigations into contraventions of legislation. When necessary, legal action is taken against the offenders by way of compounding or prosecution in court.
The spontaneous reporting of adverse drug reactions by doctors and other health professionals is also one of the important tools used by HPRG to keep continued vigilance on the safety of all marketed drugs in Singapore.
In addition, HPRG inspects and licenses pharmaceutical manufacturers and importers/wholesale dealers in accordance with current international Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards respectively. This ensures the production of good quality medicines and preservation of their quality down the supply chain from the manufacturers to distributors and retailers.
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The Innovative Therapeutics Group (ITG)
The ITG was formerly known as the Centre for Drug Evaluation (CDE). The CDE was set up under the Ministry of Health in December 1998 as a joint collaboration between the Ministry of Health and the National Science and Technology Board now known as the Agency for Science, Technology and Research (A*Star).
The ITG continues to be supported by A*Star to develop and provide the expertise to evaluate new drugs for registration in Singapore. This is part of the infrastructure for developing Singapore as a regional medical hub and a world hub for life sciences research and development.
With the growth of research and development in Life Sciences in Singapore, it is important that we are able to support the registration of new drugs and biotechnology products not previously approved in other countries. CDA's ITG will facilitate the timely introduction and availability of new and innovative quality medicines in Singapore and the region, including medicines targeted for diseases prevalent in the region.
The ITG continues to be supported by A*Star to develop and provide the expertise to evaluate new drugs for registration in Singapore. This is part of the infrastructure for developing Singapore as a regional medical hub and a world hub for life sciences research and development.
With the growth of research and development in Life Sciences in Singapore, it is important that we are able to support the registration of new drugs and biotechnology products not previously approved in other countries. CDA's ITG will facilitate the timely introduction and availability of new and innovative quality medicines in Singapore and the region, including medicines targeted for diseases prevalent in the region.
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Milestones
2004 | |
Jan 2004 | Formation of the Centre for Drug Administration from the merger of Centre for Pharmaceutical Administration and Centre for Drug Evaluation. |
2003 | |
Nov 2003 | Establishment of US FDA - HSA Medical Product Working Group under the US-Singapore Free Trade Agreement to promote the protection of public health through expeditious, science-based regulatory procedures for new medical products |
Sep 2003 | Establishment of a Memorandum of Understanding (MOU) with the State Food and Drug Administration, People's Republic of China to further enhance cooperation in drug administration. |
Jan 2003 | Implementation of additional labeling requirement for Chinese Proprietary Medicines to differentiate them from Western drugs. |
2002 | |
Nov 2002 | Implementation of the GMP Certification Scheme for manufacturers of cosmetic products. |
Sep 2002 | Singapore was appointed the Chair of the Implementation Working Group (IWG) under the ASEAN Consultative Committee for Standards and Quality Pharmaceutical Product Working Group. |
Jun 2002 | Implementation of the GMP Certification Scheme for Manufacturers of medicinal products. |
May 2002 | Enhanced technical cooperation and information exchange with the Therapeutics Goods Administration, Australia through the Memorandum of Intent for cooperation on scientific and regulatory affairs , signed by HSA and TGA. |
Mar 2002 | Singapore became a founding member of the newly formed Western Pacific Regional Forum for the Harmonisation of Herbal Medicines. |
2001 | |
Sep 2001 | Completion of Phase III Implementation of Chinese Proprietary Medicines Control. |
Apr 2001 | NPA was renamed the Centre for Pharmaceutical Administration under the newly established Health Sciences Authority. |
Feb 2001 | Establishment of Mutual Recognition Agreement (MRA) on GMP Inspection with Australia. |
2000 | |
Jan 2000 | Singapore became a member of the Pharmaceutical Inspection Cooperation Scheme (PICS). |
1999 | |
Sep 1999 | Implementation of Phase I Control of Chinese Proprietary Medicine (CPM) solid dosage forms . |
May 1999 | Singapore became a member of the Permanent Forum on International Pharmaceutical Crime. |
Apr 1999 | Pharmaceutical Department was renamed the National Pharmaceutical Administration (NPA) under the Ministry of Health. |
Jan 1999 | Launch of the first issue of the Adverse Drug Reaction News Bulletin. |
1998 | |
Dec 1998 | Formation of Centre for Drug Evaluation (CDE) to evaluate new drugs for registration in Singapore. |
Sep 1998 | Licensing of tobacco retailers came into effect. |
Jul 1998 | Establishment of the "Singapore Guidelines for Good Clinical Practice". |
1997 | |
Apr1997 | Formation of the Good Manufacturing Practice (GMP) Unit. |
1996 | |
Jun 1996 | Implementation of Cosmetic Control in Singapore. |
1995 | |
Nov 1995 | Formation of Cosmetic Control Unit to regulate cosmetic products. |
Nov 1995 | Formation of Chinese Proprietary Medicine Unit to regulate CPM products. |
1994 | |
Apr 1994 | Singapore acceded to the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce to facilitate Singapore's exports of pharmaceutical products. |
1993 | |
May 1993 | Implementation of the new Smoking (Control of Advertisements and Sales of Tobacco) Act which prohibits smoking by youths under 18 years old. |
Jan 1993 | Establishment of Adverse Drug Reaction (ADR) Monitoring Programme to detect local ADRs. Singapore subsequently became the 40th member of the WHO International Drug Monitoring Programme. |
1991 | |
Jul 1991 | Implementation of electronic submission of inward declarations for import approval of medicinal products via TradeNet. |
Mar 1991 | Establishment of Drug Information Service to provide unbiased drug information to healthcare professionals. |
1990 | |
May 1990 | Establishment of post-marketing Quality Surveillance Programme (QSP) to monitor the quality of approved medicinal products for sale in Singapore. |
1987 | |
Jun 1987 | Implementation of drug registration to ensure that medicinal products on sale in Singapore are safe, efficacious and of good quality. |
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