Regulatory Blog

Pakistan's Drug Regulatory Authority (DRAP) has finalized its guidelines for imports and exports of therapeutic goods. This document...

This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...

US Food and Drug Administration (FDA) finalized guidance for submitting postmarketing safety reports for drugs and biologics...

Malaysia's Medical Device Authority (MDA) has drafted a guidance that will assist manufacturers and authorized representatives to...

The Philippines' Food and Drug Administration (FDA) is seeking feedback on draft guideline aimed at streamlining the process of changing...

Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...

On 20 April, 2022 the Saudi Food and Drug Authority’s (SFDA’s) updated its Product Classification Guidance. This guidance presents the...

Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...

The Medical Device Authority (MDA) of Malaysia is seeking feedback on draft regulations for medical device labeling. The MDA's fifth...

On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in...

The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...

This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their...

On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining...

The Health Products Regulatory Authority (HPRA) updated its guidance on "Parallel Imports of Human Medicine" last week. Parallel...

This draft guidance document is being distributed for comment purposes only. Cybersecurity incidents have rendered medical devices and...

On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and...

As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...

On 29-March-2022, a guidance document titled "Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection"...