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FDA Concurs With WHO on Rare Lymphoma Linked to Breast Implants By Zachary Brennan - Published 21 March 2017

The US Food and Drug Administration (FDA) on Tuesday said it now concurs with the World Health Organization’s designation of an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma.

Categories: News, US, FDA, TGA, WHO, Compliance, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: breast implants, lymphoma, BIA-ALCL

Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs By Zachary Brennan - Published 06 March 2017

The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs).

Categories: News, Asia, Canada, Europe, US, EC, FDA, Health Canada, MHRA, TGA, WHO, Crisis management, Government affairs, Manufacturing

Tags: PIC/S, good manufacturing practice for ATMP, European Commission consultation

IMDRF Offers a Preview of Next Week’s Vancouver Meeting By Zachary Brennan - Published 06 March 2017

Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.

Categories: News, Asia, Canada, Europe, US, Anvisa, EC, FDA, IMDRF, TGA, WHO, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IMDRF, MDR, IVDR, MDUFA, Cures

International Generic Drug Regulators Unveil New Biowaiver Assessment Template By Zachary Brennan - Published 01 March 2017

Regulatory authorities participating in the International Generic Drug Regulators Programme (IGDRP) have crafted and released a Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template for use by its members.

Categories: News, Asia, Canada, Europe, US, CFDA, EMA, FDA, Health Canada, WHO, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: IGDRP, biowaivers, Biopharmaceutics Classification System

CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions By Yingying Liu, Siegfried Schmitt - Published 15 February 2017

To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and changes; and inspection case analysis through observations by various international regulatory authorities.

Categories: Features, China, CFDA, FDA, WHO, Government affairs, Regulatory intelligence

Tags: Chinese Center of Food and Drug Inspection, CFDI

EMA Explains How it Supports Article 58 Applications By Michael Mezher - Published 07 February 2017

The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs).

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, EMA, WHO, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Article 58, Scientific Advice, Business Pipeline Meeting

FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances By Zachary Brennan - Published 10 January 2017

The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances.

Categories: News, US, FDA, WHO, Drugs, Government affairs, Product withdrawl and retirement

Tags: cannabis, marijuana, controlled substances, DEA

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

Regulatory Recon: Two Former Pharma Execs Charged With Price Fixing; FDA Extends Comment Period for Off-Label Promo Comments (15 December 2016) By Zachary Brennan - Published 15 December 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHLW, WHO, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

WHO Prequalifies First Hepatitis C Diagnostic By Zachary Brennan - Published 05 December 2016

The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Government affairs, In vitro diagnostics, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: WHO, prequalification, Gilead, Hepatitis C

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

WHO Releases Draft Guidance on Postmarket Changes to Biologics By Michael Mezher - Published 03 November 2016

The World Health Organization's (WHO) Expert Committee on Biological Standardization (ECBS) recently released a new draft guideline detailing the agency's proposed approach to handling changes to approved biologics and biosimilars for public comment.

Categories: News, WHO, Biologics and biotechnology, Labeling, Manufacturing, Submission and registration

Tags: Biologics, Biosimilars, Postmarket Changes

WHO: New Emergencies Program Faces $200M Funding Gap By Michael Mezher - Published 31 October 2016

As part of its overall financing dialogue, the World Health Organization (WHO) gave an update on its newly formed Health Emergencies Programme (WHE), which the agency says is currently facing a $200 million funding gap.

Categories: News, WHO, Government affairs

Tags: WHO, World Health Organization, Health Emergencies Programme, WHE

Regulatory Recon: Drug Pricing Fight Heats Up; 23andMe Abandons Next-Gen Sequencing (27 October 2016) By Zachary Brennan - Published 27 October 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, NICE, TGA, WHO, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (11 October 2016) By Nick Paul Taylor - Published 11 October 2016

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

Categories: News, Asia, CDSCO, CFDA, WHO, Active pharmaceutical ingredients, Clinical, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, DCGI, India, GMPs, clinical trial applications in India

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

WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable By Zachary Brennan - Published 30 September 2016

The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: WHO, prequalification of vaccines, prequalification of medicines, WHO funds

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

Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices By Zachary Brennan - Published 14 September 2016

The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, WHO, Clinical, Distribution, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: UN High-Level Panel on Access to Medicines, UN reports on pharmaceuticals, compulsory licenses, pharmaceutical R&D

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

WHO Updates Antibiotic Treatment Guidelines for Three STIs By Michael Mezher - Published 30 August 2016

The World Health Organization (WHO) on Tuesday issued new treatment guidelines for three sexually transmitted infections (STIs) (chlamydia, gonorrhea and syphilis), saying the updates respond to an "urgent need" in light of increasing antimicrobial resistance.

Categories: News, WHO, Drugs

Tags: Sexually transmitted infection, STI

Regulatory Recon: Congress Takes Summer Vacation Without Addressing Zika (15 July 2016) By Zachary Brennan - Published 15 July 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, CFDA, EC, EMA, FDA, Health Canada, TGA, WHO, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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

Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed By Zachary Brennan - Published 23 June 2016

The public-private vaccine alliance known as Gavi on Thursday pledged $27.5 million to a pilot project that the World Health Organization is running to introduce a malaria vaccine candidate into sub-Saharan Africa.

Categories: News, Africa, WHO, Biologics and biotechnology, Government affairs, Project management, Regulatory intelligence, Submission and registration

Tags: Gavi, PATH, malaria vaccine, GSK, Gates Foundation