On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that address unmet medical needs. In addition to outlining the tools currently available to manufacturers seeking expedited approval of breakthrough
Introduction On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are currently applicable. They provide guidance for the clinical development and quality control of medicinal products containing allergens. All of these guidelines start
Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products. The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation of haemophilia B medicinal products. In July, a similar guideline was adopted concerning haemophilia A medicinal products.
Introduction The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use. New methods that are equivalent
The European Medicines Agency (EMA) has published a draft qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU. The draft Opinion was adopted by the Agency’s Committee for Medicinal Products for Human Use (CHMP). It presents CHMP’s views on the “regulatory acceptability” of eSource
Introduction On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries Initiative (PRI). The consultation period is open to stakeholders until 29 June 2019. It has been published to allow stakeholders to
Introduction The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric population came into effect on 8 November 2018. The Considerations Chapter addressed pharmacovigilance issues that frequently arise with the paediatric population and related pharmacovigilance
The reflection paper and extrapolation The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. The main focus of the reflection paper is to provide a framework and guidance for the use of extrapolation in the development of medicinal products in paediatric patients.
The concept paper The EMA has published a “Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.” In the Concept Paper, the EMA proposes to merge the “Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev 2)” with
The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, introduced a new online application. The online application makes it possible to request a cGMP Declaration (Current Good Manufacturing Practice). A cGMP Declaration can be issued by the FDA to a foreign regulator, such as the competent
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their joint task force regarding the availability of authorised medicines for human and veterinary use. The HMA-EMA task force was created
The EMA has announced that, from 15 June 2018. The Agency will cease to accept requests for access to documents by non-EU applicants. The EMA announced that the Agency’s decision was a result of the high volume of access requests and the related excessive administrative workload.
The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline to clarify the level of validation/qualification that needs to be performed by a sponsor in a clinical trial setting when using an electronic system previously qualified by a vendor. The updated Guideline, issued in the form of a Q&A document, provides that
On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice. The draft guideline provides the principles for the two step release
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
Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format (“eCTD format”).
The European Medicines Agency has published a checklist for applicants seeking qualification of novel methodologies.
The European Medicines Agency has published a guidance document for assessors written in questions-and-answers. It should be read in combination with the explanatory note to GVP module VII.
Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately.
Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a potential Brexit transition period.
On 22 September 2017, the European Medicines Agency (“EMA”) published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical data for medicinal products for human use.
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators. The new confidentiality commitment allows the regulators to share
European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to transfer the Agency’s headquarters to another EU Member State. With the aim to conserve Agency’s capacities to protect public and animal health, EMA has issued a press
With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears from a recent letter to the Financial Times (FT) that Government ministers are listening. On 3