Internationalpharmaceuticalregulatorymonitor

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December 2018

Vol. 46
No. 12

Headlines

UK Trade Groups Question MHRA’s ‘No-Deal’ Brexit Plan

Two prominent UK drug organizations say they’re “generally supportive” of MHRA’s contingency plans if the UK exits the EU on March 29 without a deal, but expressed concern about orphan drugs and centrally authorized product licenses, among other issues. Read More

U.S.-EU Partnership on GMP Inspections Adds Five Countries

The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement between the U.S. and the European Union. Read More

FDA Moves to Modernize Inspections for Sterile Injectables

The FDA is streamlining its reporting of inspections for sterile injectable drugs to help make risk-based regulatory decisions. Read More

USMCA Trade Deal Will Keep U.S. Drug Prices High, Groups Warn

The Trump administration’s newly negotiated trade deal with Canada and Mexico threatens to keep American drug prices high, two dozen-plus consumer, health, trade and other organizations warned in a letter to the U.S. Trade Representative. The 29 groups — including the Association for Accessible Medicines (AAM) and the AARP — claim some provisions in the proposed NAFTA overhaul are inconsistent with U.S. law. Read More

Advisory Committee Votes Against Definition of Opioid-Sparing Drugs

An FDA advisory committee voted against broad definitions of “opioid-sparing” and opioid-level analgesia in a Nov. 15 meeting. Read More

EMA Issues Updated Pediatric Pharmacovigilance Guidance

The European Medicines Agency’s updated guidelines on good pharmacovigilance practices took effect Nov. 8 — urging sponsors to pay particular attention to symptoms subjects may be unable to communicate. Read More

EMA Spells Out Plans to Encourage Advanced Therapy Drug Products

The European Medicines Agency issued an updated action plan to encourage advanced therapy medicinal products (ATMPs) — including the release by year’s end of draft guidelines for clinical trial sponsors. Read More

WHO Finds Wide Variations in Antibiotic Use

Some nations may be consuming too many antibiotics that the World Health Organization has determined must be reserved for emergencies to limit antibiotic resistance. Read More

Pharma Group Calls for More Incentives for Antibiotic Research

International regulators need to take action to reverse the steep decline in research and development for antibiotics, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Read More

Gottlieb Highlights Commitment to Expanded Access to Trials

Commissioner Scott Gottlieb unveiled a redesigned FDA website on expanded access to clinical trials on Nov. 8 and said the agency is “deeply committed” to helping critically ill patients with no other treatment options to join trials. Read More

EU’s Supreme Court Sides With Italian Authorities on Off-Label Uses

The EU’s supreme court has ruled that EU member state health systems can cover the cost of off-label drug uses in certain cases. Read More

Drug Safety? There (Should Be) an App for That, FDA Says

The FDA is seeking public comment on how it should regulate prescription drug software apps and says some apps might have to be regulated as a device — such as a software program that uses advanced algorithms to scan skin lesions for evidence of cancer. Read More

EMA Invites Comments on Water Quality Guideline for Drugmakers

The EMA is seeking stakeholder feedback on a draft guideline on the quality of water for pharmaceutical use. Read More

FDA Parries on Teva 180-Day Exclusivity Suit

The FDA hit back at Teva’s lawsuit accusing the agency of changing its policy on granting 180-day exclusivity for generics — arguing that the company’s attempt to block exclusivity for competing Restasis (cyclosporine) generics was “built atop a tottering tower of conjecture.” Read More

FDA Holds Sponsors Accountable for Post-Marketing Studies

FDA Commissioner Scott Gottlieb said the agency is committed to ensuring “timely completion” of post-marketing studies by drug sponsors in a statement about the agency’s latest report on the status of reviews. Read More

FDA Issues Guidance for Combination Hypertension Drugs

The FDA released final guidance for sponsors of fixed-combination hypertension drugs, with several clarifications of the draft document. Read More

Pfizer Loses Lyrica Patent Battle in UK Supreme Court

Pfizer’s appeal for a second patent on Lyrica (pregabalin) has been denied by the UK’s highest court, ending the pharma giant’s long-running fight against drug companies marketing generic versions of its blockbuster pain treatment. Read More

EMA Considers Ways to Evaluate Non-Genotoxic Drug Impurities

Drug sponsors should assess the safety of non-genotoxic impurities (NGIs) in chemically synthesized drugs on a case-by-case basis, the EMA’s Committee for Medicinal Products for Human Use suggests in a draft reflection paper released for stakeholder comment. Read More