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Regulatory Recon: FDA Approves New Shingles Vaccine; NICE Oks Gene Therapy for Rare Condition (23 October 2017) By Zachary Brennan - Published 23 October 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EC, EMA, FDA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

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

WHO Will Hold Off on Using Biological Qualifiers for Biosimilars By Zachary Brennan - Published 19 October 2017

No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report.

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Labeling, Postmarket surveillance

Tags: biological qualifier, biosimilar naming

WHO to Launch Pilot to Prequalify Biosimilars By Zachary Brennan - Published 05 September 2017

The World Health Organization (WHO) announced Tuesday that in October it will launch a pilot project for prequalifying biosimilars as part of its work to make some of the most expensive treatments for cancer more widely available in low- and middle-income countries.

Categories: News, WHO, Biologics and biotechnology, Drugs

Tags: biosimilar prequalification, WHO prequalification

IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018 By Zachary Brennan - Published 31 August 2017

The International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) have agreed to consolidate their work into a joint initiative that is expected to be operational in January 2018.

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, Health Canada, ICH, MHRA, WHO, Drugs, Regulatory intelligence, Regulatory strategy

Tags: IPRF, IGDRP, pharmaceutical regulations

Regulatory Recon: J&J Pays $417M for Baby Powder Link to Cancer (22 August 2017) By Zachary Brennan - Published 22 August 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, PMDA, WHO, Drugs, Government affairs, Medical Devices

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

Bioequivalence Studies of Solid Oral Dosage Forms Overview By Sharry Arora - Published 16 August 2017

The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.

Categories: Features, EMA, FDA, Health Canada, MHLW, PMDA, TGA, WHO, Generic drugs

Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability

FDA Considers WHO Scheduling Change for 17 Drug Substances By Zachary Brennan - Published 11 August 2017

The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs.

Categories: News, US, FDA, WHO, Crisis management, Drugs, Government affairs

Tags: drug substances, fentanyl, opioids, cannabis

FDA Commissioner Scott Gottlieb’s Keynote Among Highly Anticipated Sessions at RAPS Regulatory Convergence By Zachary Brousseau - Published 10 August 2017

RAPS will host its annual Regulatory Convergence conference at the Gaylord National Resort and Convention Center at National Harbor on the DC waterfront 9–12 September. This year’s event features more than 75 educational sessions and over 200 speakers, including an opening keynote from FDA Commissioner Scott Gottlieb.

Categories: HTML, Articles, Under RAPS, Anvisa, EMA, FDA, MHRA, PMDA, WHO, RAPS

WHO Drafts New Prequalification Timeline, KPIs By Zachary Brennan - Published 07 August 2017

As part of efforts to better monitor and improve the performance of its prequalification program, the World Health Organization (WHO) has proposed a new algorithm to calculate the prequalification timeline and drafted new key performance indicators (KPIs) to track. 

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Drugs, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: WHO prequalification

Pharmaceutical Cleaning Processes By John Godshalk, MSE, MBA - Published 26 July 2017

This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification.

Categories: Features, FDA, WHO, Drugs

Tags: Cleaning, Washing, Rinsing, Cleaning Validation

Regulatory Recon: FDA Panel to Focus on Safety of CAR-T Therapy (10 July 2017) By Zachary Brennan - Published 10 July 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

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

Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July By Gloria Hall - Published 05 July 2017

Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars.

Categories: Features, Africa, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHLW, TGA, WHO, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles

Biological Products and Biosimilars: Global Naming Debate By Pallavi Trivedi - Published 27 June 2017

This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, WHO, Biologics and biotechnology, Submission and registration

Tags: Biosimilars, Biosimilar Naming, Biological Qualifier, INN

WHO to Craft Essential Diagnostics List By Zachary Brennan - Published 16 June 2017

The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL).

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, WHO, Due Diligence, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: WHO essential diagnostics, EDL, Essential medicines list

Caribbean Regulatory System Begins Recommending Generic Drugs By Zachary Brennan - Published 14 June 2017

The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) last month kicked off its work advising Caribbean countries’ governments by assessing and recommending four generic HIV treatments.

Categories: News, Latin America and Caribbean, FDA, WHO, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Caribbean medicines, Caribbean drug regulators, WHO, PAHO, Caribbean Regulatory System

WHO Essential Medicines Update Adds Antibiotic use Framework and new HCV & HIV Drugs By Michael Mezher - Published 06 June 2017

The World Health Organization (WHO) on Tuesday announced updates to its essential medicines list (EML), including new recommendations for antibiotic use and the addition of new drugs to treat hepatitis C, HIV and leukemia.

Categories: News, WHO, Biologics and biotechnology, Drugs

Tags: Essential Medicines List

WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns By Michael Mezher - Published 02 June 2017

The World Health Organization Prequalification Team (WHO-PQT) said this week that it is no longer concerned about the quality of prequalified products made at Mylan Pharmaceuticals' Nashik, India site after the US Food and Drug Administration (FDA) warned the site over quality system issues in April.

Categories: News, India, FDA, WHO, Drugs

Tags: WHO Prequalification, Mylan, Nashik

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