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Focus on Regulation

Tag Archives: guidance

European Commission publishes new documents regarding the Clinical Trials Regulation

1.            Introduction Shortly after updating the related draft Questions and Answers document (see our blog), the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form.

Use of ethanol in medicinal products: European Medicines Agency publishes guidance concerning safety information for the package leaflet

1.               Introduction On 22 November 2019, the European Medicines Agency (“EMA”) published an updated Annex to the European Commission’s Guidelines concerning excipients in the labelling and package leaflet of medicinal products for human use. This updated Annex provides a list of the excipients for which specific information should appear in the package leaflet. The list

European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

1.               Introduction The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing clinical trials within the Regulation. The draft document has been submitted for discussion to the Expert Group on Clinical Trials.

Heads of Medicines Agencies publishes practical guidance on nitrosamines

1.            Introduction In late October 2019, the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) of the Heads of Medicines Agencies (HMA) published a practical guidance on nitrosamines. The guidance is addressed to marketing authorisations holders (MAHs) of products medicinal products authorised nationally in the EU Member States and through the mutual

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

1.            Introduction On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers and notified bodies and provides guidance on the presentation, content and validation of the SSCP under the Medical Devices Regulation

European commission publishes Additional Guidance regarding the Medical Devices Vigilance System

The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), provide for the requirement for a European Medical Devices Vigilance System. The Medical Devices Vigilance System is the European system for the notification and evaluation of incidents

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic Medical Devices Regulation (“IVDR”). The MDR and IVDR will apply from May 2020 and May 2022 respectively. These documents include: Factsheet for

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives for innovators to invest in further research.  On July 19, FDA also published the guidance “Labeling for Biosimilar Products,” finalizing an April

FDA proposes new ways for prescription drugs to become available over-the-counter

On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a prescription, drugs that are currently available only by prescription.  The draft guidance would facilitate these prescription (Rx) to Over-The-Counter (OTC) switches by allowing

New version of EMA’s pre-authorisation procedural advice for the centralised procedure released

On 4 May 2018, the European Medicines Agency (“EMA”) published another updated version of the guidance document on pre-authorisation for users of the centralised procedure. The document contains revisions regarding the EMA marketing authorisation application numbers. It also includes changes related to oral explanations during the assessment procedure of the marketing authorisation application. Background The

EMA Publishes New GMP Guidance on Data Integrity

The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance concerning measures intended to ensure data integrity throughout the “data lifecycle” from generation of data, processing, use in decision making, to disposal. The document provides a set of frequently asked questions and answers for companies that process data generated in the process

Product Design and Safety Considerations

The FDA issued its final guidance for the industry on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, three years after the draft was first published.

FDA Notifies Applicants of Intent to Require Sweeping Changes to Labeling for IR Opioid Analgesics and Entire Class of Prescription Opioids

FDA has announced its intent to require new class-wide labeling requirements for immediate-release (IR) opioid pain medications including new black and other safety warnings.  The enhanced warnings are intended “to inform prescribers and patients of additional risks related to opioid use.”  FDA, News Release (March 22, 2016) (hereinafter, “News Release”).  FDA further announced its intent

EMA’s new guidance on publication of clinical data

On 3 February 2016 European Medicines Agency (“EMA’s”) introduced new External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use(“the New External Guidance”).

EMA Updates Product Information Templates for Medicinal Products for Human Use

On 10 June 2015, the European Medicines Agency published the revised Human Product Information templates for medicinal products in the European Union (“EU”). The revised Quality Review of Documents (“QRD”) template concerning centralised procedures is most notably affected by this update. The update introduces certain modifications to the Human Product Information template and is intended

Clarifying the duty to have regard

The High Court has found that the duty “to have regard to” guidance requires that guidance to be taken into account, and for there to be “clear” reasons for any departure from it, but that it does not go so far as to require a “compelling justification” for a departure. The recent case of R

EMA publishes draft guidance on medication errors for public consultation

On 14 April 2015, the European Medicines Agency (“EMA”) published three draft guidance documents concerning medication errors for consultation. The new European Union (“EU”) laws and regulations governing pharmacovigilance activities require reports of suspected adverse reactions arising from an error associated with the use of a medicinal product to be reported to EudraVigilance. To support

FDA Announces Enforcement Discretion in Implementing the DSCSA’s Product Tracing Requirements, Delaying Enforcement until May 1, 2015

FDA recently issued a Guidance document announcing that it will exercise its discretion not to enforce the product tracing requirements of the Drug Supply Chain Security Act (DSCSA) until May 1, 2015.  The Guidance, entitled DSCSA Implementation:  Product Tracing Requirements — Compliance Policy, is being implemented immediately.  Under the DSCSA, the product tracing requirements for