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Filtering on: "organizations agencies/organizations ich"

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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

Regulatory Harmonization Initiatives By Mukesh Kumar, RAC, Eliane Barras, MSc, Lewis Lau, RAC - Published 09 May 2017

This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.

Categories: Features, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, APEC, GHTF, ICH, IMDRF, ISO, OECD, WHO, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Harmonization

Researchers Link Target Product Profiles to Shorter Review Times By Michael Mezher - Published 17 April 2017

A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Labeling, Quality, Regulatory strategy, Submission and registration

Tags: Target Product Profile, TPP, Quality Target Product Profile, QTPP

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 Updates on New Members, Progress on Guidelines By Zachary Brennan - Published 08 February 2017

The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, Biologics and biotechnology, Compliance, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANVISA, BIO, MFDS, CECMED, MCC, S11, GCP, regulatory guidance

Regulatory Intelligence - Delivering Regionally, Operating Globally By Emily Huddle, BSc, Soufiane Dib, PharmD, Marie Claire Aquilina, MPharm, MSc - Published 25 January 2017

This article discusses the impact of the Internet with regard to the amount and transparency of information offered by regulatory health agencies with an emphasis on the role of regulatory intelligence in monitoring the global environment and the subsequent communication obtained from this information.

Categories: Features, EMA, FDA, ICH, Drugs, Regulatory intelligence

ICH Working Group to Provide More Detailed Guidance By Zachary Brennan - Published 23 January 2017

The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues.

Categories: News, Canada, Europe, US, ICH, Clinical, Crisis management, Drugs, Quality

Tags: MedDRA, pharmaceutical company guidance, medication errors

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

International Generic Drug Regulators Outline Plans for Collaboration Through 2020 By Zachary Brennan - Published 09 January 2017

As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.

Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs

FDA Officials Call for Including Adolescents in Adult Oncology Trials By Michael Mezher - Published 20 December 2016

A team of officials at the US Food and Drug Administration (FDA) are calling for a "culture shift" by drugmakers, regulators and clinical investigators to encourage enrolling more adolescent patients in relevant "adult-type" cancer clinical trials.

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

Tags: Pediatric oncology, Adolescent oncology

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

Four Pharma Companies Lead in Regulatory, Legal Compliance By Zachary Brennan - Published 14 November 2016

Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Bill & Melinda Gates Foundation’s Access to Medicines Index.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, WHO, Biologics and biotechnology, Drugs

Tags: pharmacovigilance, pharmaceutical regulatory compliance, Gilead, Sanofi, Takeda, Pfizer, Novartis, Takeda, Gates Foundation, pharma regulations

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

China Food and Drug Administration Issues New Requirements for Clinical Trial Applications and New Drug Applications By Gretchen Dean, MA, Joel Hardink, MBA, MS - Published 17 October 2016

This article discusses the growth of China's pharmaceutical market, background of the global use and acceptance of the Common Technical Document (CTD), outlines the China Food and Drug Administration (CDFA) requirements for Clinical Trial Application (CTA) approval and New Drug Application (NDA) registration as critical steps in addressing drug quality, patient safety and shortening the time for access to new drugs.

Categories: News, China, CFDA, ICH, Clinical, Drugs, Submission and registration

Tags: Electronic common technical document, eCTD, Clinical trial application, CTA,

UK’s MHRA and Swissmedic Pledge Closer Collaboration By Zachary Brennan - Published 11 October 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday announced it will forge closer ties with its Swiss counterpart, Swissmedic, via a Memorandum of Understanding (MoU) signed as part of the 11th Summit of the Heads of Medicines Regulatory Agencies in Interlaken, Switzerland.

Categories: News, Europe, EMA, ICH, MHRA, WHO, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Swissmedic, regulatory collaboration, Heads of Medicines Regulatory Agencies

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

Destination Cuba: Regulator Prepares for Influx of Novel US Pharmaceuticals By Zachary Brennan - Published 20 September 2016

With the restoration of diplomatic relations betweeen the US and Cuba in late 2014, the island is prepping for a wave of new and generic US pharmaceuticals and biologics, the head of the Havana-based regulatory agency, known as the Center for State Control of Drugs, Medical Devices (CECMED), told Focus in an exclusive interview.

Categories: News, Latin America and Caribbean, US, EMA, FDA, ICH, WHO, Biologics and biotechnology, Drugs

Tags: Cuba, Cuba embargo, lung cancer vaccine Cuba, Cuba drug regulations

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

Updated: FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections By Zachary Brennan - Published 29 June 2016

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are making significant progress toward mutually recognizing each other’s good manufacturing practice (GMP) pharmaceutical inspections.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, US, Anvisa, EMA, FDA, ICH, MHRA, TGA, WHO, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: ICMRA, GMP inspections, mutual recognition, FDA and EMA relationship