Page 27 - PharmBio2122_25June21
P. 27

                                                                                                                                                                                                                                          SINGAPORE PHARMBIO GUIDE 2021/2022
                                                                                                                                                                                                                   in Singapore. Stringent requirements for facility, work procedures and biosafety management systems are also stipulated in the Act. Permits for the import, possession and production of these biological agents and toxins are also required prior to initiation of the said works. More information, including the updated list of regulated agents and toxins, is available at the Ministry of Health’s biosafety website (
In addition, import of clinical and pathological specimens must comply with the requirements laid down in the Agri- food and Veterinary Authority (AVA)’s Veterinary Regulations For The Importation of Products Of Animals and Birds (1/1) – Clinical / Pathological Specimens and any subsequent amendments. Prior approval from AVA is also needed for all imports of plants and plant products as well as veterinary biologics and microorganisms (select agents) into Singapore. More information is available at AVA’s website (
Licence Related
to Possession of Radioactive Materials
The Radiation Protection and Nuclear Science Department (RPNSD) under the National Environmental Agency (NEA) regulates the use of radioactive materials and irradiating apparatus in Singapore.
Guidelines are published by the agency on the possession and use
of ionising radiations, which include emissions of alpha and beta particles (i.e. most radioisotopes frequently used in a molecular biology or chemistry lab) as well as gamma rays and X-rays.
Under the Radiation Protection Act, a licence is needed for the import, export, sale, possession and use of radioactive materials and apparatus. In addition, personal radiation monitoring is required for all personnel handling such materials and apparatus. Proper storage and accountability of the radioactive materials in one’s possession are also imperative. More common licences include the L4, L6 and R1 licences, which are applicable to companies that wish to possess radioactive materials for their own use as well as individuals who wish to be registered as radiation workers respectively. On the other hand, N2 and N3 licences are applicable for companies interested in using radiation-generating equipment such as ultrasonic, magnetic resonance imaging or laser equipment. Further details along
with the applications forms are available at the NEA’s website ( sg). Such premises are also subjected to routine inspection by officers from RPNSD.
Genetic Modification Advisory Committee (GMAC)
The GMAC oversees and advises on research and production of Genetically Modified Organisms (GMOs) in Singapore. The committee has since published guidelines pertaining to the control of release of agriculture-related GMOs as well as biosafety guidelines for research on GMOs. Specifically, the latter guidelines provide the framework for assessment and notification of research on GMOs. Certain works involving genetic manipulation of organisms must be approved by the institution’s Institutional Biosafety Committee (IBC) and GMAC notified. More information on the guidelines, which was recently updated in 2020, may be found at

   25   26   27   28   29