GMP News - Pharmaceutical Development / Clinical Trials / GCP

24.01.17

Once again Critical Inspection Findings at two Indian Study Sites

Critical violations in view of the inspected studies as well as serious deficiencies in the quality management system of two Indian study sites were found during GCP inspections. Read more on the findings of the GCP inspections conducted at two Indian Sites.

24.01.17

FDA publishes Q&A Paper "Use of Electronic Informed Consent"

The U.S. Food and Drug Administration (FDA) recently published a Questions and Answers (Q&A) guidance on the use of electronic informed consent in clinical investigation. Read more about the FDA Guidance "Use of Electronic Informed Consent Questions and Answers".

08.12.16

EMA's Concept Paper on Non-Clinical Documentation for Herbal Medicinal Products published

In July 2016 EMA's Working Group on herbal medicinal products (HMPC/Committee on Herbal Medicinal Products) published a concept paper on the revision of the guideline on non-clinical documentation for herbal medicinal products. Now in particular genotoxic tests have to be included. Read more about the concept paper on the revision of the guideline on non-clinical documentation for herbal medicinal products.

08.12.16

ICH M9: Biopharmaceutics Classification System-based Biowaivers

In October 2016, the International Council for Harmonisation (ICH) endorsed a new topic for the development of a new multidisciplinary guideline M9. Read more about Biopharmaceutics Classification System (BCS)-based biowaivers.

03.11.16

FDA´s Drug Safety Draft Guidance regarding REMS

The Food and Drug Administration (FDA) published a draft drug safety guidance for industry for comment. Read more about "FDA´s application of statutory factors in determining when a REMS is necessary".

03.11.16

FDA Guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation"

To assist pharmaceutical manufactureres in the development, analysis, and presentation of microbiology data during antibacterial drug development, the FDA published a guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation".

02.08.16

Proposals to revise EU Guidance on first-in-human Clinical Trials

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials.

02.08.16

Updated Standards for Bioequivalence Studies: WHO publishes Revised Guidance for CROs

WHO's guideline for clinical research organisations performing in vivo bioequivalence studies has been extensively revised and recently published. Read more in the News about which requirements are now binding for CROs with regard to the QM system and electronic data management.

02.08.16

ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process

The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles on planning/designing Multi-Regional Clinical Trials (MRCTs). Read more about the ICH E17 General Principles for planning and design of multi-regional Clinical Trials.

12.07.16

Storage and Transport: New USP Chapter for Investigational Drug Products

The USP has proposed a new chapter as an addition to the Good Storage and Distribution Practices for Drug Products chapters, focusing on investigational drug products.

12.07.16

FDA Draft Guidance on Critical Quality Attributes for Chewable Tablets

On June 16, 2016, the US Food and Drug Administration, FDA, published a draft guidance on "Quality attribute considerations for chewable tablets". Read more about the critical quality attributes recommended for chewable tablets.

30.06.16

Important FDA Guideline on Combination Products published

During the development of combination products, "Human Factors Studies" have been gaining importance with regard to design and development. After the FDA had received many requests on how to perform such studies, a new Draft Guidance on Human Factors Studies in Combination Product Design and Development has been elaborated.

14.06.16

New Definition for Auxiliary Medicinal Products (AMPs)

The EU Commission has launched four public consultations on recommendations related to clinical trials. One of them defines IMPs and Auxiliary Medicinal Products (AMPs) (previously called Non-Investigational Medicinal Products - NIMPs).

14.06.16

QP Declaration for IMPs: some Questions and Answers

The MHRA Inspectorate has published a set of Question and Answers on the import of Investigational Medicinal Products (IMPs) in a blog.

14.06.16

EMA reviews approvals based on data of Semler Research Centre Private Ltd, Bangalore, Indien

On April 29, 2016, the European Medicines Agency (EMA) has started a review of approvals based on studies conducted at Semler Research Centre Private Ltd, Bangalore, India. Find out more about the EMA- referral concerning studies of Semler.

Page 25 of 32

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GMP News - Pharmaceutical Development / Clinical Trials / GCP

Once again Critical Inspection Findings at two Indian Study Sites

FDA publishes Q&A Paper "Use of Electronic Informed Consent"

EMA's Concept Paper on Non-Clinical Documentation for Herbal Medicinal Products published

ICH M9: Biopharmaceutics Classification System-based Biowaivers

FDA´s Drug Safety Draft Guidance regarding REMS

FDA Guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation"

Proposals to revise EU Guidance on first-in-human Clinical Trials

Updated Standards for Bioequivalence Studies: WHO publishes Revised Guidance for CROs

ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process

Storage and Transport: New USP Chapter for Investigational Drug Products

FDA Draft Guidance on Critical Quality Attributes for Chewable Tablets

Important FDA Guideline on Combination Products published

New Definition for Auxiliary Medicinal Products (AMPs)

QP Declaration for IMPs: some Questions and Answers

EMA reviews approvals based on data of Semler Research Centre Private Ltd, Bangalore, Indien

Recommended Event

Pre-Conference Course Fundamentals of Visual Inspection State-of-the-art Visual 100% Inspection

GMP News - Pharmaceutical Development / Clinical Trials / GCP

Once again Critical Inspection Findings at two Indian Study Sites

FDA publishes Q&A Paper "Use of Electronic Informed Consent"

EMA's Concept Paper on Non-Clinical Documentation for Herbal Medicinal Products published

ICH M9: Biopharmaceutics Classification System-based Biowaivers

FDA´s Drug Safety Draft Guidance regarding REMS

FDA Guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation"

Proposals to revise EU Guidance on first-in-human Clinical Trials

Updated Standards for Bioequivalence Studies: WHO publishes Revised Guidance for CROs

ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process

Storage and Transport: New USP Chapter for Investigational Drug Products

FDA Draft Guidance on Critical Quality Attributes for Chewable Tablets

Important FDA Guideline on Combination Products published

New Definition for Auxiliary Medicinal Products (AMPs)

QP Declaration for IMPs: some Questions and Answers

EMA reviews approvals based on data of Semler Research Centre Private Ltd, Bangalore, Indien

Recommended Event

Pre-Conference Course Fundamentals of Visual Inspection State-of-the-art Visual 100% Inspection

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