Search Results for Harmonization

Showing 1 – 25  of 62

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

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

EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses By Zachary Brennan - Published 13 February 2017

With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: PBPK modeling and simulation, EMA and FDA harmonization, Bayer, Merck, Novartis

European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017) By Nick Paul Taylor - Published 12 January 2017

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: regulatory harmonization, ICMRA, Bayer, biologic quality standards

US, EU Look to Mutually Recognize GMP Inspections by January 2017 By Zachary Brennan - Published 26 October 2016

The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GMP inspections, regulatory harmonization, UDIs, quality inspections

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

Pharmaceutical Regulators Propose Principles for Indication Extrapolation for Biosimilars By Zachary Brennan - Published 06 September 2016

The International Pharmaceutical Regulators Forum’s (IPRF) Biosimilars Working Group (BWG) on Tuesday released a reflection paper outlining principles that regulators around the world can use for extrapolating indication(s) during the authorization process for new biosimilars.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, EMA, FDA, Health Canada, MHLW, MHRA, PMDA, TGA, WHO, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IPRF, biosimilar regulatory harmonization, biosimilar applicants, follow-on biologics

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

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

EU Proposes More Structured Convergence With FDA on Pharma Regulations By Zachary Brennan - Published 26 May 2016

The European Union has offered a new proposal that would further harmonize the pharmaceutical regulations between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which could speed new drug approvals and manufacturing inspections in both regions.

Categories: News, Europe, US, EC, EMA, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing

Tags: regulatory convergence, regulatory harmonization, FDA and EMA collaborations

Former FDA and NIH Heads Call for Regulatory Harmonization By Zachary Brennan - Published 11 May 2016

Former US Food and Drug Administration (FDA) commissioner Margaret Hamburg and former National Institutes of Health (NIH) director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine.

Categories: News, Africa, Asia, Canada, Europe, US, CDSCO, EMA, FDA, GHTF, Health Canada, ICH, IMDRF, MHRA, WHO, Active pharmaceutical ingredients, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regulatory harmonization, regulatory convergence, Margaret Hamburg, Sanofi

ICH Looks to Global Expansion By Zachary Brennan - Published 06 May 2016

The newly renamed International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is looking to bring more pharmaceutical and medical device regulators into its ranks as members and observers.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, ICH, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regulatory harmonization, pharmaceutical regulators

Asia Regulatory Roundup: Dengue Vaccine Nears Approval in India Without Local Phase III Data (19 January 2016) By Nick Paul Taylor - Published 19 January 2016

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

Categories: News, Asia, CDSCO, CFDA, MHLW, PMDA, Clinical, Drugs, Government affairs, Medical Devices

Tags: CFDA, DCGI, Pharmexcil, Dengue, regulatory harmonization

IMDRF Participants Outline Plans for Next Week’s Meeting in Japan By Zachary Brennan - Published 08 September 2015

In anticipation of the International Medical Device Regulators Forum (IMDRF) stakeholders meeting in Japan next week, participating countries’ regulators, trade groups and others have outlined a number of updates they plan to share.

Categories: News, GHTF, IMDRF, Medical Devices

Tags: CDRH, IMDRF, medical devices, device harmonization

Harmonization Creates Opportunities for Both Regulatory Professionals and Agencies in Developing Countries By Obaid Ali, RPh, MPhil, PhD and Roohi B. Obaid, RPh, MPhil - Published 16 July 2015

This article  discusses how the regulatory profession in  developing countries can benefit from global regulatory harmonization.

Categories: Articles, Features, India, Middle East, FDA, ICH, MHRA, TGA

Tags: harmonization, developing countries

FDA, Health Canada Continue Efforts to Promote Regulatory Cooperation By Alexander Gaffney, RAC - Published 03 June 2015

US and Canadian healthcare product regulators are continuing to move forward in a joint effort to harmonize the way in which both countries regulate pharmaceuticals, medical devices, biological products and veterinary drugs.

Categories: News, Canada, US, FDA, Health Canada, Biologics and biotechnology, Drugs, Medical Devices, Veterinary products

Tags: RCC, Regulatory Cooperation Council, Harmonization

ICH Takes Step Toward New eCTD Version By Michael Mezher - Published 24 February 2015

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD).

Categories: News, Japan, Europe, US, EMA, FDA, ICH, PMDA, Submission and registration

Tags: ICH, International Conference on Harmonization, eCTD, electronic submissions

Out of Africa: Six Regulatory Articles that Span the Continent By Janet Aker, Managing Editor, Regulatory Focus - Published 16 February 2015

Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southern Africa, West Africa, Central Africa, Northern Africa and South Africa. The articles contain the regulatory agency contacts/responsible parties for countries in each geographic area. The collection also includes an articles on RCOREs.

Categories: Features, Africa, Drugs, Government affairs, Project management, Submission and registration

Tags: Africa, South Africa, Northern Africa, North Africa, West Africa, Central Africa, East Africa, Southern Africa, RCOREs, regional centres of excellence, submission, submission and registration, dossier, regulatory submission, regulatory training, regulatory strategy, WHO, NEPAD, East African Community, EAC, regulatory challenges, harmonization, ministry of health, ministere de la sante

South Africa Medicines Regulatory System Overview By Elias Nyberg and Emma Burr Nyberg - Published 30 January 2015

South Africa’s pharmaceutical regulating body, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals. In the last decade, limited resources have meant increased review timelines. To ensure a timely and successful application, it is crucial for pharmaceutical companies to facilitate open discussions and exchange information with key MCC regulators, listed herein.

Categories: Features, Africa, Drugs, Government affairs, Submission and registration

Tags: South Africa, Medicines Control Council, responsible pharmacist, harmonization initiative, CTD, dossier

FDA Adopts International Photosafety Testing Standard By Alexander Gaffney, RAC - Published 27 January 2015

New guidance published by the US Food and Drug Administration (FDA) would bring the US into alignment with an international standard meant to ensure new drug products don't cause photosensitivity in patients.

Categories: News, US, FDA, ICH, Active pharmaceutical ingredients, Clinical, Drugs

Tags: Photosafety, S10, ICH, International Conference on Harmonization, Guidance, Final Guidance, Phototoxicity, Photosensitivity, Photoallergy

The Southeast Asian Regulatory Environment for Pharmaceuticals (Part 1) By Ravi Varahalu and Jairam Masetti - Published 03 December 2014

A two-part series on the Southeast Asian regulatory environment for pharmaceuticals describes the regulatory landscape in each of the 10 Association of Southeast Asian Nations (ASEAN) countries and attempts to capture some of the key elements that companies should consider when planning to enter ASEAN markets. Part 1 presents information on the larger markets of Singapore, Malaysia, Thailand, the Philippines and Indonesia. Part 2 will discuss Brunei, Vietnam, Laos, Myanmar (Burma) and Cambodia.

Categories: Features, Asean, Distribution, Drugs, Submission and registration

Tags: ASEAN, pharmaceuticals, Asian markets, regulatory review, Singapore, Malaysia, Thailand, Philippines, Indonesia, harmonization

AHWP Finalizes Document Meant to Form Backbone of Software Regulation Approach By Alexander Gaffney, RAC - Published 31 October 2014

The medical-device focused Asian Harmonization Working Group (AHWP) has released a new document meant to eventually help provide a common approach for the regulation of medical device software.

Categories: News, Africa, Asia, Middle East, Medical Devices

Tags: AHWP, SaMD, Software, Software as a Medical Device, White Paper, Asian Harmonization Working Party

US, Canada Continue to Push for Regulatory Harmonization in the Life Sciences By Alexander Gaffney, RAC - Published 02 September 2014

US and Canadian regulators are continuing to work together to harmonize the way in which they regulate pharmaceuticals, biologics, over-the-counter drugs, medical devices and veterinary products, both governments confirmed in an update this week.

Categories: News, Canada, US, CBER, CDER, CDRH, Health Canada, ICH, IMDRF, Biologics and biotechnology, Over the counter drugs, Prescription drugs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration, Veterinary products

Tags: RCC, Regulatory Harmonization, ICH, PICS, ICDRA, IPRF

IMDRF Moves Forward With Effort to Standardize Global Device Submissions By Alexander Gaffney, RAC - Published 14 August 2014

The International Medical Device Regulators Forum (IMDRF) has released two final documents that, once implemented, should make it much easier to get medical device products approved in multiple regions, including the US, EU and Canada.

Categories: News, China, Japan, Canada, Europe, US, IMDRF, In vitro diagnostics, Medical Devices, Submission and registration

Tags: RPS, Regulated Product Submission, Harmonization, Table of Contents, RPS ToC

Health Canada, SwissMedic Join ICH as Steering Committee Members By Alexander Gaffney, RAC - Published 11 July 2014

The International Conference on Harmonization (ICH), the influential international pharmaceutical regulatory harmonization body, has elected to add two new regulators to its Steering Committee, the group has announced.

Categories: News, Japan, Canada, Europe, US, ICH, Drugs

Tags: ICH Steering Committee, ICH Meeting, ICH Update, SwissMedic, Regulatory Harmonization