Guidelines:
A. Approved PI and PIL of all registered drug products shall be published by the FDA in the Verification Portal System at https://verification.fda.gov.ph and shall be updated monthly.
B. All MAHs
Regulatory News
Singapore HSA Implements GMP Evidence for Drug Substance Manufacturers
As part of a continual regulatory enhancement to ensure the quality standard of therapeutic products supplied in Singapore, Singapore’s Health Sciences Authority (HSA) will roll out a transition plan for
Singapore HSA Revises Medical Device Adverse Events Reporting Guideline
Singapore HSA revised GN-05: Guidance on the Reporting of Adverse Events for Medical Devices with the following update:
– Included new section regarding Adverse Event Investigation
– Listed regulatory actions that HSA
Singapore HSA Updates Medical Device Adverse Event Reporting Form
Singapore’s Health Sciences Authority (HSA) updated the Medical Device Adverse Event Reporting Form for Medical Device Dealers (MDAR1 Form). As a management committee member of the International Medical Device Regulators
Singapore HSA Updates Health Supplement & Traditional Medicines Labelling Guideline
HSA updates GUIDELINES FOR LABELLING STANDARDS OF HEALTH SUPPLEMENTS AND TRADITIONAL MEDICINES including clarification on labelling requirements on the name and address of local dealers for products manufactured in Singapore
Singapore HSA Accepts MDSAP certification for Medical Device’s QMS Certification
Singapore HSA included Medical Device Singapore Audit Program (MDSAP) certification as one of the acceptable lists of Medical Device’s QMS Certifications for medical device dealers (including manufacturer, importer and wholesaler).
Accordingly,
Singapore HSA Updates Advertisement Guidance for Therapeutic Products
Singapore’s Health Sciences Authority (HSA) updated EXPLANATORY GUIDANCE TO THE HEALTH PRODUCTS (ADVERTISEMENT OF SPECIFIED HEALTH PRODUCTS) REGULATIONS for Therapeutic Products (TP) Advertisement.
Minor revisions include:
– Redefining the list and terms
Singapore HSA Updates Guidance on the Risk Classification of IVD Medical Devices (GN-14)
Singapore’s Health Sciences Authority (HSA) has finalised the updated GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices, based on the various feedback and comments received from
Malaysia MDA Updates on the Approach to Expired EC Certificate for New Registration and Re-registration of Medical Device
MDA has taken an approach to allow expired EC Certificates to be used for conformity assessment procedures due to the unpredictable timeline and issues with regards to the transition to