GMP News - Pharmaceutical Development / Clinical Trials / GCP
GMP News - Pharmaceutical Development / Clinical Trials / GCP
04.02.14
New EMA Guidance Qualification of novel Methodologies for Drug Development
The European Medicines Agency EMA has published the revised Guidance to Applicants "Qualification of novel methodologies for drug development". Read more.
The U.S. Food and Drug Administration FDA has issued a draft guidance to define how the agency intends to deal with requests to import unapproved drug products. Read more.
EMA publishes Guideline on Pharmaceutical Development of Medicines for Paediatric Use
The European Medicines Agency has published the final Guideline on pharmaceutical development of medicines for paediatric use. The date for coming into effect is 15 February 2014. Read more.
PLAIR - new FDA Guideline regulates Import of non-approved Drugs in the Run-Up to the Launch in US
Under certain circumstances unapproved bulk or finished products can be imported in the United States before granting the marketing authorisation. For this purpose the FDA recently described a new standardised approach in a draft of a "Guidance for Industry". What pharmaceutical companies have to consider prior to launching their products in the United States you can read here.
New Requirements of the FDA on Stability Testing of Generic Drugs
The stability data required in an application for the authorisation of a generic medicinal product for the American market have been redefined in a new FDA Guideline. Read more here.
Classification of Dosage Forms according to the USP
The USP divides the pharmaceutical dosage forms into 5 groups and wants to elaborate new General Chapters to depict the quality and performance requirements specific to each of these 5 dosage forms. The current status of implementation is addressed in an interesting article of the Pharmacopeial Forum. Read more.
QP Template for IMPs manufactured in third Countries
The EU Commission has published the final Template for the Qualified Person's Declaration of Equivalence to EU GMP for IMPs manufactured in third countries. It seems that they accepted some proposals made by stakeholders in their comments. Read more.
ICH publishes New Draft Guideline on Genotoxic Impurities
A new ICH draft guideline on genotoxic impurities in APIs and medicinal products should help compensate shortcomings in existing regulations on the topic. The requirements of this guideline also concern medicinal products which are already available on the market. Read more here.
The European Commission has published a draft template for the QP's declaration concerning GMP compliance of IMPs manufactured in non-EU countries. Read more.