Malaysia Revised Drug Registration Process Guidance
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has revised its drug registration guide. The updated document addresses quality control, inspections and other steps in the drug registration process and features product-specific labeling requirements for eight more therapies than its predecessor.
NPRA introduced the second version of its Drug Registration Guidance document in 2016 and has revised it three times since then. The majority of the document has remained unchanged throughout the revision process, with NPRA using the updates to add new information rather than overhaul the existing text. As such, each version has provided an overview of products covered by the guidance, a walkthrough of the registration process and information about quality control and inspections.
Changes between the January 2019 version of the document and the latest text include the addition of product-specific labelling information for another eight medicines. The latest document has specific labelling information for 221 products.
Beta-lactam antibiotics, including combination products, are among the medicines to be covered by product-specific labelling requirement. NPRA is requiring manufacturers to add a warning about the risk of “serious and occasionally fatal hypersensitivity reaction.” The agency wants healthcare professionals to make “careful” inquiries whether a patient has previously suffered from hypersensitivity reactions and stop treatment immediately if they respond badly to a beta-lactam.
Other changes include the addition of warnings about the link between hydrochlorothiazide and types of cancer, cases of pathological immune activation in patients taking lamotrigine and the risk of depression in patients taking systemic retinoids.
For more detailed information on eCTD specification refer below links.
https://www.npra.gov.my/index.php/en/drug-registration-guidance-documents-drgd-e-book.html
