GMP News - Pharmaceutical Development / Clinical Trials / GCP

03.05.16

New FDA Guidance on "Safety by Design"

On April 11, 2016, the FDA released a new guidance on "Safety Considerations for Product Design to Minimize Medication Errors". The guidance provides a set of principles for using a systems approach to minimize medication errors relating to drug product design and container closure design to enhance patient safety. The recommendations in this guidance apply to the development stage of drug and biologic products. Find out more about the new FDA guidance on "Safety by design".

03.05.16

EMA is starting a review concerning studies at Alkem, India

Following a good clinical practice (GCP) inspection at the Alkem Laboratories Ltd site in Taloja, India, which raised concerns regarding study data used to support EU marketing authorisation applications, the European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted at this site. Read more about the start of a review regarding study data generated at the Alkem Laboratories Ltd site in Taloja, India.

22.03.16

GCP Inspection Findings published

The UK MHRA has compiled a GCP Inspections Metrics Report summarising 125 GCP Inspections.

22.03.16

IMPs: Responses to the public consultations on new GMP Regulations published

Last year, the EU Commission has published four public consultations on investigational medicinal products (IMPs). The feedback is now available.

22.03.16

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.

22.03.16

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.

20.01.16

FDA´s Emerging Technology Applications Program - Draft Guidance

The FDA recently published a draft guidance for industry on the "Advancement of Emerging Technology Applications". The draft guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of CMC information containing emerging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".

13.01.16

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).

22.10.15

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.

07.10.15

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.

30.09.15

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.

30.09.15

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.

02.09.15

IMPs: Four new public consultations concerning GMP and GCP published

The EU Commission has published four new public consultations on Investigational Medicinal Products (IMPs). They focus on both GMP and GCP.

07.08.15

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.

15.01.15

Draft: New Clinical Trial Rules in India

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.

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GMP News - Pharmaceutical Development / Clinical Trials / GCP

New FDA Guidance on "Safety by Design"

EMA is starting a review concerning studies at Alkem, India

GCP Inspection Findings published

IMPs: Responses to the public consultations on new GMP Regulations published

EMA publishes GVP Module V (Revision 2) for public comment

New FDA Guidance on Extent of Safety Data in Late Stage and Postapproval Clinical Investigations

FDA´s Emerging Technology Applications Program - Draft Guidance

FDA publishes two Draft IND Guidances for Comments

Investigational Medicinal Products - Recent Changes in EC Guidance

Revision of the ICH Guideline Q3C: New toxicological Data for Methyl Isobutyl Ketone and Triethylamine

New FDA Requirements for the Development of Herbal Medicinal Products

Genotoxic impurities: the new ICH M7 addendum to calculation of compound-specific acceptable intakes

IMPs: Four new public consultations concerning GMP and GCP published

An Addendum to ICH M7 provides practical Examples to calculate compound-specific Acceptable Intakes

Draft: New Clinical Trial Rules in India

Recommended Event

The GMP-Compliance Manager

GMP News - Pharmaceutical Development / Clinical Trials / GCP

New FDA Guidance on "Safety by Design"

EMA is starting a review concerning studies at Alkem, India

GCP Inspection Findings published

IMPs: Responses to the public consultations on new GMP Regulations published

EMA publishes GVP Module V (Revision 2) for public comment

New FDA Guidance on Extent of Safety Data in Late Stage and Postapproval Clinical Investigations

FDA´s Emerging Technology Applications Program - Draft Guidance

FDA publishes two Draft IND Guidances for Comments

Investigational Medicinal Products - Recent Changes in EC Guidance

Revision of the ICH Guideline Q3C: New toxicological Data for Methyl Isobutyl Ketone and Triethylamine

New FDA Requirements for the Development of Herbal Medicinal Products

Genotoxic impurities: the new ICH M7 addendum to calculation of compound-specific acceptable intakes

IMPs: Four new public consultations concerning GMP and GCP published

An Addendum to ICH M7 provides practical Examples to calculate compound-specific Acceptable Intakes

Draft: New Clinical Trial Rules in India

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The GMP-Compliance Manager

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