International Accreditation, Liaisons and Agreements
Membership of PIC/S
With effect from 1 January 2000, Singapore has become the first Asian country to accede to Pharmaceutical Inspection Co-operation Scheme (PIC/S). Accession to PIC/S (which is based in Geneva, Switzerland), would bring about many benefits to Singapore and the pharmaceutical manufacturing sector. These include the enhancement of the status of Singapore as a regional pharmaceutical and life sciences hub, the facilitation of the process of mutual recognition on GMP inspection with PIC/S countries and the global acceptance of the quality of pharmaceutical products manufactured and exported from Singapore.
WHO Certification on Quality of Pharmaceutical Product
Singapore is a party to the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. HSA is the competent authority for Singapore for the granting of a Certificate of a Pharmaceutical Product and the Certificate of Licensing Status of a Pharmaceutical Product in accordance with the WHO Certification Scheme.
1971 United Nations Convention on Psychotropic Substances
Singapore is a party to the 1971 United Nations Convention on Psychotropic Substances. HSA is the competent authority for Singapore with respect to the granting of import authorizations and export licences for internationally-controlled psychotropic substances (e.g. benzodiazepines, central nervous system stimulants, etc), and the submission of adhoc, quarterly and annual statistical reports to the International Narcotics Control Board (INCB), based in Vienna, on the importation, exportation and other legitimate international dealings of psychotropic substances in and out of Singapore.
1961 United Nations Single Convention on Narcotic Drugs
Singapore is a party to the 1961 United Nations Single Convention on Narcotic Drugs. HSA is the competent authority for Singapore with respect to the granting of import and export licences for narcotic drugs (controlled in Singapore under the Misuse of Drugs Act and Regulations), and the submission of adhoc, quarterly and annual statistical reports to INCB, on the importation, exportation and other legitimate international dealings of narcotic drugs in and out of Singapore.
Australia-Singapore MRA on GMP Conformity Assessment
A Mutual Recognition Agreement (MRA) on GMP conformity assessment between Australia and Singapore was signed in Canberra on 26 February 2001. The agreement is of treaty status and includes the sector on Medicinal Product GMP Inspection. Under the MRA, Therapeutic Goods Administration, Australia shall accept the conclusions of inspections of manufacturers carried out by GMP Auditors of HSA, Singapore and vice-versa. The GMP inspection report/certificate shall be made available to the requesting party expeditiously, and the time taken shall not exceed 30 calendar days.
ASEAN Sectoral Mutual Recognition Arrangement For GMP Inspection Of Manufacturers Of Medicinal Products
An ASEAN Sectoral Mutual Recognition Arrangement (MRA) on Good Manufacturing Practice (GMP) Inspection of manufacturers of medicinal products was signed on 10 April 2009 in Pattaya Thailand by the Economic Ministers of the 10 ASEAN Member States.
The scope and coverage of this Sectoral MRA is for medicinal products in finished dosage forms, and excludes products such as biopharmaceuticals, radiopharmaceuticals, traditional medicines and investigational medicinal products. Under this Sectoral MRA, a Party whose Inspection Service is listed under this Sectoral MRA will have its Inspection Reports and GMP Certificates, in respect of a facility manufacturing medicinal products in its territory, recognized and accepted by other ASEAN Member States. In order for an Inspection Service to be listed under this Sectoral MRA, the Inspection Service shall operate a Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP inspection system, as demonstrated by PIC/S membership or adherence to any other equivalent standard. As Singapore is already a PIC/S member, it would mean that Singapore HSA would become one of the Listed Inspection Service under the Sectoral MRA. As such, other ASEAN Member States would therefore recognize and accept HSA's GMP certificates and inspection reports of our local manufacturers of medicinal products, without the need to conduct another audit on our local manufacturers.