PRIME is a European Medicines Agency (EMA) initiative to increase assistance for the development of medicines that address an unmet medical need. Through PRIME, the Agency provides early and proactive support to drug developers to maximise the production of reliable data on a medicine’s benefits and risks and to allow accelerated assessment of drug applications. […]
The FDA is proposing to establish norms for a non-prescription medication with an additional condition for non-prescription use (ACNU). If implemented, the proposed rule would establish requirements for a non-prescription drug product with an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers who are not […]
“The format of the cover letter attachment can be customized by the applicant according to their convenience. The primary purpose of the cover letter attachment is to assist applicants in ensuring that they address relevant information in any cover letter they submit to the FDA for the submissions mentioned in this guidance. The cover letter […]
INDUSTRY CONSULTATION ON ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) IMPLEMENTATION IN SINGAPORE Overview HSA is planning to introduce eCTD to enable full e-submissions thereby minimising the need for submitting documents using storage media such as CD/DVD ROMs. HSA is working with our appointed vendor to develop the eCTD system (ICH eCTD version 3.2.2) in Singapore. The […]
Holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year before April 1 in order to continue doing business. Those with a suspended MDEL are exempt from applying. An annual licence review (ALR) ensures that MDEL holders are: Adhering to regulatory requirements Maintaining their licence information up […]
According to FDA regulations, if an applicant wishes to pursue approval of its Abbreviated New Drug Application (ANDA), applicant must submit all materials required to fully address all shortcomings in the Complete Response Letter (CRL) within one year of the CRL’s issuance. The applicant must submit a request for an extension on or before the […]
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Revising abbreviated new drug applications (ANDAs) Labeling Following Revision of the reference listed drugs (RLDs).” In this guidance, FDA is providing information on How ANDA applicants and holders should monitor for changes to RLD labeling: The sponsor […]
Version 4.0 of the electronic Common Technical Document (eCTD) is the upcoming next major version of the electronic submission format. CDER and CBER plan to accept new applications in eCTD v4.0 format in 2023. The current version, v3.2.2, which is used by most global health authorities, including US FDA, EMA, Canada, Japan, and many others. […]
Taiwan Food and Drug Administration (TFDA) released guidelines for eCTD specification. Following countries such as the USA, EU, Japan, Australia, Canada and Switzerland, Taiwan will soon adopt the eCTD standard.
A meeting has been held by US-Food & Drug Administration for explaining the concept of new FDA form 3938 for the submission of Drug Master File to FDA. The agenda for the meeting was to explain the concept of Form 3938, the details of the form, purpose of the form, when should the form 3938 […]