Search Results for ICH

Showing 1 – 25  of 43

ICH Transparency: New Info on Funding, Expert Working Groups By Zachary Brennan - Published 17 October 2017

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.

Categories: News, Asia, Canada, Europe, US, ICH, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: ICH funding, E9, E11, S5

FDA Offers New ICH Guidance on Organizing a CTD By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA.

Categories: News, Canada, Europe, US, FDA, ICH, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: eCTD, common technical document, ICH guidance

ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation By Michael Mezher - Published 29 September 2017

The International Council for Harmonisation (ICH) is planning to take up two new topics, according to the minutes released Thursday from the group's meeting in Montreal in May and June.

Categories: News, ICH, Biologics and biotechnology, Clinical, Drugs, Quality

Tags: ICH Assembly, Montreal, E8(R1), Pediatric Extrapolation

Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations By Michael Mezher - Published 18 September 2017

The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), and agency officials on Monday laid out key considerations for sponsors.

Categories: News, US, FDA, Biologics and biotechnology, Drugs

Tags: Quantitative Benefit-Risk Assessment, ICH M4E(R2)

EMA Opens Consultations of Two Revised ICH Guidelines By Zachary Brennan - Published 31 August 2017

The European Medicines Agency (EMA) on Thursday released for consultation a revised ICH guideline on reproductive toxicology and an addendum to another guideline on statistical principles for clinical trials.

Categories: News, Canada, Europe, US, EMA, ICH, Clinical, Drugs

Tags: ICH E9, ICH S5

ICH Details Pilot Training Programs for 2017 By Michael Mezher - Published 16 August 2017

The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan.

Categories: News, Japan, Europe, US, ICH, Clinical, Drugs, Manufacturing, Submission and registration

Tags: ICH, Training, eCTD, GMP, GCP

ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data By Michael Mezher - Published 26 July 2017

The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection.

Categories: News, FDA, ICH, Clinical, Drugs

Tags: Safety Data, ICH, International Conference for Harmonization, E19

European Regulatory Roundup: Swissmedic Proposes Overhaul of Drug Ordinances (29 June 2017) By Nick Paul Taylor - Published 29 June 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: EC, EMA, MHRA, Drugs, Government affairs

Tags: Swiss drug ordinances, ICH E2E, CVMP

Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017) By Nick Paul Taylor - Published 27 June 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, ICH, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: priority review, China in ICH, CFDA backlog, Indian pharmaceuticals

ICH Expands MedDRA's Uptake Globally By Michael Mezher - Published 12 June 2017

The International Council for Harmonization (ICH) on Monday touted the global expansion of its Medical Dictionary for Regulatory Activities (MedDRA) and provided updates on other activities related to MedDRA.

Categories: News, ICH

Tags: ICH, MedDRA, Medical Dictionary for Regulatory Activities

ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Vijayalakshmi Iyer - Published 16 May 2017

This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.

Categories: Features, Europe, US, FDA, ICH, Biologics and biotechnology, Drugs, Quality

Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD

EMA’s Pediatric Committee Seeks to Tweak ICH Q&A on Nonclinical Evaluation of Cancer Drugs By Zachary Brennan - Published 13 February 2017

The European Medicines Agency’s (EMA) Pediatric Committee has offered a couple of comments, slight tweaks and further suggestions for the International Council for Harmonisation’s (ICH) draft question and answer document on its S9 guideline on the nonclinical evaluation for anticancer pharmaceuticals.

Categories: News, Europe, EMA, ICH, Biologics and biotechnology, Clinical, Drugs

Tags: PDCO, EMA committee, ICH Q&A, S9

ICH Offers Reflection Paper on Good Clinical Practice Revisions By Zachary Brennan - Published 12 January 2017

The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct.

Categories: News, Asia, Canada, US, ICH, Clinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: Good Clinical Practice, ICH guidance, ICH E6, ICH E8

Japan Joins International API Manufacturing Inspection Program By Zachary Brennan - Published 15 December 2016

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs).

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Active pharmaceutical ingredients, Manufacturing

Tags: ICH Q7, API manufacturing inspections

ICH Advances Three Guidance Documents By Zachary Brennan - Published 02 December 2016

The International Council for Harmonisation (ICH) earlier this week advanced two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase.

Categories: News, Africa, Asia, Canada, Europe, US, FDA, ICH, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Q11, Q3C(R6), E6(R1), ICH guidelines, drug manufacturing

FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format By Zachary Brennan - Published 29 November 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: ICH guidance, PSUR, PAER, PADER, PBRER

FDA Begins Consultation on Update to ICH Pediatric Clinical Trials Guidance By Michael Mezher - Published 21 November 2016

The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Ethics, Regulatory strategy

Tags: Pediatric drug development, ICH E11

ICH Looks to Revamp GCP Guidelines, Adds New Members By Michael Mezher - Published 17 November 2016

Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week.

Categories: News, Anvisa, ICH, MFDS, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy

Tags: ICH, International Council for Harmonisation, Good clinical practice, GCP, Real world evidence

ICH Proposes Two New Guidelines By Zachary Brennan - Published 21 October 2016

The International Council for Harmonisation (ICH) has announced the creation of two new guidelines, with one (M9) providing recommendations to support the biopharmaceutics classification of medicinal products, while the other (M10) applies to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies.

Categories: News, Asia, Canada, Europe, US, ICH, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: ICH, bioanalytical methods, biopharmaceutics classification

WHO Seeks API Manufacturers for Prequalification Program By Zachary Brennan - Published 10 October 2016

The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, ICH, WHO, Active pharmaceutical ingredients, Crisis management, Due Diligence, Government affairs, Manufacturing

Tags: WHO prequalification program, API manufacturing, ICH, regulatory authorities and WHO

ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join By Zachary Brennan - Published 12 September 2016

While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future.

Categories: News, Asia, Europe, US, CDSCO, CFDA, FDA, ICH, Compliance, Crisis management, Drugs, Manufacturing

Tags: ICH, PIC/S, data integrity, pharmaceutical guidance, international pharmaceutical harmonization

FDA Begins Consultation on Two ICH Guidelines By Michael Mezher - Published 08 September 2016

The US Food and Drug Administration (FDA) has issued two new International Council for Harmonisation (ICH) guidelines for public consultation: one on multi-regional clinical trials (MRCTs) and one on microsampling in study animals.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: Multi-regional clinical trials, Microsampling, ICH

ICH Adds 14 New Observers, Adopts New Guidelines at Lisbon Meeting By Zachary Brennan - Published 01 July 2016

The recently renamed International Council for Harmonisation (ICH) is adding new pharmaceutical and medical device regulators, industry groups and the US Pharmacopeia into its ranks as observers.

Categories: News, Asia, Canada, Europe, Oceania, US, Anvisa, CDSCO, CFDA, EMA, FDA, Health Canada, ICH, MHRA, PMDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: ICH observers, pharmaceutical regulatory harmonization

FDA Issues New Draft Guidance on Elemental Impurities By Michael Mezher - Published 30 June 2016

The US Food and Drug Administration (FDA) on Thursday issued new draft guidance on elemental impurities in drugs, with the goal of helping manufacturers comply with recent International Council for Harmonisation (ICH) and United States Pharmacopeial Convention (USP) standards.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Manufacturing, Submission and registration

Tags: Elemental Impurities, ICH Q3D

FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics By Zachary Brennan - Published 22 June 2016

The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: ISCRs, ICH, eCTD, E2B(R3)