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UK MHRA Guidance: Early Access to Medicines Scheme
The Early Access to Medicines Scheme (EAMS) is a regulatory initiative in the United Kingdom designed to provide patients with life-threatening or seriously debilitating conditions earlier access to promising medicines before full marketing authorisation is granted. The scheme is administered by the Medicines and Healthcare products Regulatory Agency (MHRA) and aims to accelerate patient access to innovative treatments where there is a clear unmet medical need. The main obj
Sharan Murugan
2 days ago3 min read
USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles
Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...
Sharan Murugan
Apr 24, 20221 min read
SFDA's Product Classification Guidance
On 20 April, 2022 the Saudi Food and Drug Authority’s (SFDA’s) updated its Product Classification Guidance. This guidance presents the...
Sharan Murugan
Apr 24, 20221 min read
Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines
Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...
Sharan Murugan
Apr 24, 20221 min read
Malaysia’s MDA- Draft Medical Device Labeling Guidance
The Medical Device Authority (MDA) of Malaysia is seeking feedback on draft regulations for medical device labeling. The MDA's fifth...
Sharan Murugan
Apr 24, 20221 min read