Internationalpharmaceuticalregulatorymonitor

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June 2018

Vol. 46
No. 6

Headlines

FDA Approves New Drugs Faster Than Five International Agencies

The increased use of fast track regulatory pathways has led to the FDA having the shortest median approval time for new active drug substances in 2017 compared to five other international regulatory agencies, according to the UK-based Centre for Innovation in Regulatory Science (CIRS). Read More

EU Proposal Would Boost Manufacture of Generic Drugs and Biologics Exclusively for Export

The European Commission proposes to grant waivers to Europe’s drugmakers to produce generic drugs for export to countries outside the EU. Read More

China to Crack Down on Drug Companies

Chinese regulators plan to crack down on corruption and unfair competition in the pharmaceutical sector, its government has announced. Read More

FDA Issues Draft ICH Guidance on Product Lifecycle Management

The FDA released the ICH’s Q12 draft guidance on pharmaceutical product lifecycle management (PLCM) for post-approval changes in chemistry, manufacturing and controls. Read More

FDA Reference Drug List Flags Companies That Hinder Generics

In an effort to curb the “gaming tactics” that delay generic drug competition, the FDA released a public list of companies found to be potentially restricting access to samples of their branded products. Read More

EMA Conducts Fewer GMP, More GCP and Pharmacovigilance Inspections

The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year. Read More

MHRA Cites Data Management and Integrity in GCP Inspections

Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Read More

Time Between FDA Inspections and Classification Letters Shrinking

The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, according to one of the agency’s top inspection officials. Read More

Stakeholders Urge Tweaks in Draft Guidance on Pregnant Trial Subjects

The FDA’s draft guidance on inclusion of pregnant women in clinical trials needs some fine tuning, according to stakeholders, including more clarity on non-adherence to therapies. Read More

TGA Overhauls Advisory Committee Conflicts of Interest Guidance

Australia’s Therapeutic Goods Administration revised its guidelines for confidentiality obligations and conflicts of interest for members of advisory committees, overhauling the guidance with major content and structural changes. Read More

FDA Clarifies ‘Outsourcing Facility,’ Requirements for 503A Compounders

The FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Read More

FDA Generic Drug Approvals Inch Upwards

ANDA applications remain sluggish while generic drug approvals creep upward after a drop at the start of the year, the FDA said, reporting 67 generic approvals and 57 ANDA applications for May. Read More

Semiannual Agenda Flags Upcoming FDA Regulatory Actions

HHS released its latest regulatory agenda for in-development rulemakings including 20 specific to the FDA. Read More

Final Guidance on IRB Written Procedures Allows ‘Flexibility’

Institutional Review Boards must comply with the Code of Federal Regulations in their written procedures but they have some flexibility with regard to the format and content, according to new HHS guidance. Read More

CDER Shifts Dispute Resolution Program Due to Spike in Appeals

An increased number of generic appeals has led CDER to transfer the management of its Formal Dispute Resolution program for sponsors of user fee products from the Office of New Drugs to the Office of Executive Programs, CDER Director Janet Woodcock said in a staff memo. Read More