Search Results for ICH

Showing 1 – 25  of 34

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)

ICH Genomic Sampling Guidance: FDA Begins Consultation By Michael Mezher - Published 02 June 2016

The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic sampling.

Categories: News, US, EC, FDA, Health Canada, ICH, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs

Tags: ICH, International Conference for Harmonization, E18, Genomic Sampling

Seven Pharmaceutical Regulators and NIH Collaborate to Build Drug Ingredient Database By Zachary Brennan - Published 20 April 2016

Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information.

Categories: News, Canada, Europe, US, EMA, FDA, Health Canada, ISO, WHO, Active pharmaceutical ingredients, Compliance, Crisis management, Postmarket surveillance, Quality

Tags: API database, ANSM, Swissmedic, ICH, NCATS

On Eliminating Two-Year Rat Carcinogenicity Studies for Pharma: ICH Seeks More Data By Zachary Brennan - Published 12 April 2016

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) will continue to study for two more years whether guidance can be revised on certain situations when sponsors will not have to conduct and submit a two-year rat carcinogenicity study for a developing drug.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, ICH, MHLW, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, Preclinical

Tags: ICH, S1 Guidance, rat carcinogenicity studies, pharmaceutical studies

Rodent Carcinogenicity Testing: Changes to ICH Guidance Proposed By Zachary Brennan - Published 02 March 2016

The European Medicines Agency (EMA) is considering changes to International Council for Harmonisation (ICH) guidance on rodent carcinogenicity testing to improve the evaluations, reduce use of animals and drug development resources and reduce timelines to market authorization in some cases without compromising patient safety.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, ICH, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development

Tags: carcinogenicity testing, animal drug testing, pharmaceutical testing, toxicity testing, ICH

ICH Makes Organizational Changes By Zachary Brennan - Published 26 October 2015

The International Conference on Harmonisation (ICH) has renamed itself as the International Council for Harmonisation (ICH) and has now become a legal entity under Swiss law.

Categories: News, Japan, Canada, Europe, US, EMA, FDA, PMDA, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: ICH, PhRMA, EFPIA, PMDA, EMA, FDA

European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015) By Nick Paul Taylor - Published 22 October 2015

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

Categories: News, Europe, EMA, ICH, Drugs, Due Diligence, Postmarket surveillance, Quality, Regulatory intelligence, Research and development, Veterinary products

Tags: EMA, MEB, CHMP, veterinary antibiotics, ICH, Pradaxa

Amended ICH GCP Guideline Addresses Evolution of Trials Landscape By Zachary Brennan - Published 29 September 2015

The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline with the aim of helping industry address the increasing scale, complexity and cost of clinical trials.

Categories: News, Canada, Europe, US, ICH, Clinical, Compliance, Drugs, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: ICH, clinical trials guidelines, GCP guideline, clinical trial quality

Japan Edges out FDA for Fastest Approvals By Michael Mezher - Published 31 July 2015

In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs).

Categories: News, Japan, Europe, US, EMA, FDA, MHLW, PMDA, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: New drug approvals, New active substance, NAS, Centre for Innovation in Regulatory Science, CIRS, ICH, Orphan drugs, Expedited review, Priority Review

FDA Outlines Policy on Use of Near Infrared Analysis to Test Drug Quality By Alexander Gaffney, RAC - Published 30 March 2015

New guidance issued by the US Food and Drug Administration (FDA) is intended to help pharmaceutical companies use near infrared (NIR) technology to better ensure the quality of their manufactured drug products.

Categories: News, US, CDER, Active pharmaceutical ingredients, Drugs, Manufacturing, Quality

Tags: Draft Guidance, Guidance, NIR, Near Infrared, ICH Q2 (R1)