EMA publishes GVP Module V (Revision 2) for public comment
Module V of the Guideline on Good Pharmacovigilance Practice (GVP) has been revised by the European Medicines Agency (EMA). Deadline for Comments is May 31, 2016. Module V covers the topic "Risk Management". Find out more about the revised GVP Module V.
New FDA Guidance on Extent of Safety Data in Late Stage and Postapproval Clinical Investigations
On February 18, 2016, the U.S. Food and Drug Administration, FDA, published a new Guidance for Industry on "Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations". Find out more about the new selective approach to safety data collection.
FDA´s Emerging Technology Applications Program - Draft Guidance
The FDA recently published a draft guidance for industry on the "Advancement of Emerging Technology Applications". The draft guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of CMC information containing emerging manufacturing (including testing, packaging and labeling, and quality control) technology to FDA. Find out more about the draft guidance for industry "Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base".
FDA publishes two Draft IND Guidances for Comments
Two FDA draft guidances regarding INDs have been published for comments in December 2015: "Best Practices for Communication Between IND Sponsors and FDA During Drug Development" and "Safety Assessment for IND Safety Reporting". Find out more about the draft guidances on investigational new drug applications (INDs).
Investigational Medicinal Products - Recent Changes in EC Guidance
As a consequence of implementation of the Clinical Trial Regulation 536/2014 four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products were opened August 28, 2015. It is expected that Annex 13 will be deleted from EudraLex Vol 4 when the new guidelines "Detailed Commission guidelines on GMP for IMPs for human use" become operational. Find out more about the current changes in EU regulations regarding IMPs.
Revision of the ICH Guideline Q3C: New toxicological Data for Methyl Isobutyl Ketone and Triethylamine
The guideline ICH Q3C on residual solvents is one of the most frequently revised ICH documents as a result of new scientific findings. The draft ICH Q3C(R6) was recently published. Find out here what manufacturers of active pharmaceutical ingredients and excipients must observe with regard to toxicity and solvents.
New FDA Requirements for the Development of Herbal Medicinal Products
The previous FDA guideline for herbal medicinal products from 2004 is supposed to be replaced by a new version. In August 2015, the FDA has presented the draft of the revised guideline. Find out more about the FDA Guideline Botanical Drug Development.
Genotoxic impurities: the new ICH M7 addendum to calculation of compound-specific acceptable intakes
The draft for a guideline ICH M7(R1) published recently supplements the ICH-M7 guideline published last year. Read more about the calculation of compound-specific acceptable intakes of genotoxic impurities.
An Addendum to ICH M7 provides practical Examples to calculate compound-specific Acceptable Intakes
An Addendum to the ICH M7 Guideline was recently published. Please find more details about the new Addendum, e.g. examples to calculate acceptable intakes for specific compounds known to be carcinogenic which are described in this document.
India's Central Drugs Standard Control Organization has published new draft regulations for clinical trials. One goal is to include a rule on compensation. Read more.
The European Medicines Agency (EMA) has published a summary report about the findings in GCP inspections conducted worldwide in the last years. Read more here.
Guideline "ICH Q3D - Elemental Impurities" published as Step 4 Document!
More than one year after the publication of the ICH Q3D Guideline on "Elemental Impurities" as "Draft Consensus Guideline" (Step 2B document), the final Guideline has now been released. Compared to the draft of 2013 the main changes relate to the limits of the daily absorption of metallic impurities in the different dosage forms. Read more here.
ICH Working Group Elaborates Training Materials on ICH Q3D
In two recently published documents, the ICH has informed about the establishment of an "Implementation Working Group" for ICH Q3D "Elemental Impurities" and the elaboration of training materials on the requirements of this guideline. Read more here.