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Challenges Providing Pharmaceutical Products to Syrian Refugees By Zeina Sahloul - Published 24 May 2017

This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality.

Categories: Features, Middle East, WHO, Crisis management, Drugs, Submission and registration

Tags: Syrian Refugee Crisis, Prequalification, UNHCR, Essential Medicines, MSF

WHO Elects First African Director-General By Zachary Brennan - Published 23 May 2017

The World Health Organization (WHO) on Tuesday announced that Dr. Tedros Adhanom Ghebreyesus of Ethiopia has been elected by member states as the new Director-General of WHO.

Categories: News, Africa, WHO, Government affairs

Tags: Director-General WHO

Regulatory Recon: FDA Approves New Rheumatoid Arthritis Treatment; Alexion C-Suite Overhaul (23 May 2017) By Zachary Brennan - Published 23 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, 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

Regulatory Recon: WHO Hosts 70th World Health Assembly; AstraZeneca Sells Rights to Heart Drug for $300M (22 May 2017) By Zachary Brennan - Published 22 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, US, FDA, MHLW, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

WHO Officials Offer Opposition to Value-Based Drug Pricing By Zachary Brennan - Published 12 May 2017

World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing systems.

Categories: News, Asia, Canada, Europe, US, NICE, WHO, Biologics and biotechnology, Drugs, Government affairs

Tags: WHO on drug pricing, fair pricing forum, pharmaceutical pricing

Regulatory Recon: French Regulators Halt ALS Trial; FDA Revisits Opioid Prescriber Training (12 May 2017) By Zachary Brennan - Published 12 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Canada, Europe, US, CFDA, EMA, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

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

WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall By Michael Mezher - Published 04 May 2017

The World Health Organization (WHO) on Thursday announced it will invite biosimilar makers to participate in a pilot program to prequalify biosimilars of two top selling biologics this September in an effort bring lower cost versions of the products to low- and middle-income countries.

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

Tags: Biosimilars, Prequalification, Rituxan, Herceptin, Rituximab, Trastuzumab

Regulatory Recon: Drug Shortages Can Spur Price Increases for Similar Drugs (13 April 2017) By Zachary Brennan - Published 13 April 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, WHO, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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

WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site By Zachary Brennan - Published 12 April 2017

A Chinese manufacturer of the active pharmaceutical ingredient (API) for the birth control drug levonorgestrel has been placed on the US Food and Drug Administration’s (FDA) import alert list, causing the World Health Organization (WHO) to scramble to find a replacement.

Categories: News, China, US, FDA, WHO, Active pharmaceutical ingredients, Manufacturing

Tags: birth control, Plan B, pre-qualified manufacturers, API manufacturer

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

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

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

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