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DRUG REGULATORY AFFAIRS INTERNATIONAL DRUG REGULATORY AFFAIRS INTERNATIONAL BY DR ANTHONY CRASTO

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DRUG REGULATORY AFFAIRS · 1W ago

Report from the EMA-FDA QbD pilot program

Report from the EMA-FDA QbD pilot program In March 2011, the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) launched, under US-EU Confidentiality...
DRUG REGULATORY AFFAIRS · 3M ago

EMA publishes Q&A on Health Based Exposure Limits – Does the 1/1000 dose criterion come again into play in Cleaning Validation?

In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in ...
DRUG REGULATORY AFFAIRS · 3M ago

Thailand Drug regulatory Update, Take a peep

http://www.fda.moph.go.th/eng/index.stm [PDF]Regulatory Requirement for the Approval of generic Drug in Thailand … http://www.jpsbr.org/index_htm_files/JPSBR14RV4029.pdf Apr 13, 2014 – Thail...
DRUG REGULATORY AFFAIRS · 3M ago

FDA publishes Final Guideline on GMP for Combination Products

In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the differences between the draft and ...
DRUG REGULATORY AFFAIRS · 3M ago

GMP’s for Early Stage Development of new Drug substances and products

GMP’s for Early Stage Development of New Drug substances and products The question of how Good Manufacturing Practice (GMP) guidelines should be applied during early stages of development co...
DRUG REGULATORY AFFAIRS · 4M ago

EMA issues new Guideline on “Chemistry of Active Substances”

The new EMA “Guideline on the chemistry of active substances” represents the current state of the art in regulatory practice and fits into the context of the ICH Guidelines Q8-11. Find out w...
DRUG REGULATORY AFFAIRS · 4M ago

Selection and justification of starting materials: new Questions and Answers to ICH Q11 published

  The ICH Q11 Guideline describing approaches to developing and understanding the manufacturing process of drug substances was finalised in May 2012. Since then the pharmaceutical industry a...
DRUG REGULATORY AFFAIRS · 5M ago

Generics: FDA´s New Guidance on Prior Approval Supplements

Generics: The US Food and Drug Administration (FDA) recently published a new Guidance regarding Prior Approval Supplements (PAS). Read more about FDA´s Guidance for Industry “ANDA Submission...
DRUG REGULATORY AFFAIRS · 5M ago

EMA/ FDA Mutual Recognition Agreement on drug facility inspections moving forward

EMA/ FDA Mutual Recognition Agreement moving forward A possible agreement between the EMA and the US FDA on mutual recognition agreement on drug facility inspections could already be signed ...
DRUG REGULATORY AFFAIRS · 5M ago

Opportunities for Reducing Sampling and Testing of Starting Materials

Chapter 5 of the EC GMP Guide for the area of production was updated last year. This chapter contains concrete information about the conditions when testing and sampling of APIs and excipien...