The Health Sciences Authority (HSA) of Singapore and the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labor and Welfare (MHLW) together with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan met in Singapore to sign an agreement that states that parties involved will exchange information on regulations with regards to drugs, medical devices, and cosmetics (quasi-drug included).
The regulatory information that will be exchanged includes advance drafts of legislation and regulatory guidance documents, as well as information pertaining to the authorization and supervision of medical products for human use. All parties of this agreement are to adhere to the confidentiality of the exchanged information.
The purpose of this agreement is to improve pre- and post-market regulatory issues of medicines, medical devices and cosmetics, to allow both parties of the agreement to acquire an understanding of the other party’s regulations, and to guarantee the safety and efficacy of medicines, medical devices, and cosmetics in both Singapore and Japan.
However, there are limitations to this exchange of information. Some occasions in which the dissemination of information will be limited are if it leads to disclosure of a trade secret, or is inconsistent with respective laws or public interest.
The agreement took effect on May 15 and was signed by the Chief Executive Officer of the HSA, the Director-General of the Pharmaceutical and Food Safety Bureau of the MHLW, and the Chief Executive of the PMDA.