In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s initiative for patient registries focuses mainly on the ways in which existing patient registries could be improved. This could be systematically considered
The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of medicinal products for human use. The report identifies shortcomings concerning the SmPC and the PIL, and provides recommendations on the way in which SmPC and PIL could be improved.
In an effort to help assessors evaluate initial marketing authorization applications, the European Medicines Agency (EMA) has taken the initiative to extend the use of “early background summaries”.
The French sunshine regulations require industry to report certain agreements along with the fees and other benefits provided to various stakeholders in the healthcare sector. Sunshine regulations were amended in January 2016 to increase transparency. Some specifics of these changes were partly established by an implementing decree dated 28 December 2016. Through the publication of
By Ministerial Circular of 23 March 2017, the Ministry of Health clarified the conditions under which unauthorised medicinal products may be purchased abroad within the procedure laid down by the Ministerial Decree of 11 February 1997.
On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of Clinical Trial Authorisation (CTA) applications. The Guidance is intended to assist clinical trial sponsors in identifying avoidable delays, to the benefit of
On March, 1st 2017, by Order of its Vice-President, the Court of Justice of the EU (“CJEU”) upheld the suspension of the release to third parties of a clinical study report concerning the medicinal product Translarna granted by the General Court in July 2016. On the same day, by Order of its Vice-President, the CJEU
The EMA has launched a public consultation on its draft new Policy/0043 on access to documents. The document describes the EMA’s approach in balancing public and private interests involved in requests for access to documents received by the Agency.
On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU: “Decision No 1/2017 of 1 March 2017 of the Joint Committee established under Article 14 of the Agreement
In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition
Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative will allow national competent authorities not only to participate actively in the development of new medicinal products, but also to be involved in the extensions of marketing authorisations for
As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain investigational drugs publicly available. That deadline—Saturday, February 11, 2017—arrives in a matter of days.
On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health. The Sunshine Act introduces several substantial changes to the current Belgian legal and regulatory framework for medicinal products and medical devices. Background The Sunshine Act imposes a
On January 18, 2017, as one of the last actions of the outgoing Obama administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the “Agencies”) issued a final rule overhauling the regulations (82 Fed. Reg. 7149, Jan. 19, 2017) intended to safeguard individuals participating in research, often referred to
In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a reference biological medicinal product authorised in the EU.
UK Secretary of State for Health, Jeremy Hunt, has stated in a Health Select Committee meeting that he does not expect the UK to remain part of the European Medicines Agency (“EMA”) or the EU medicines regulatory framework post-Brexit, but that the UK should seek a very close working relationship with the EMA and the
On January 17, 2017, just in time to evade the President’s Regulatory Freeze Memorandum, FDA announced the availability of a final guidance entitled “Assessment of Abuse Potential of Drugs.” The guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their drug product has
It’s no secret that the life sciences industry has had some challenging moments with lawmakers in recent years. And despite efforts by the White House, Congress, FDA, and other regulatory agencies, in most cases the law continues to lag behind the industry’s pace of innovation. So, how will the Trump Administration address the industry’s challenges?
On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of the centralised procedure (“the guidance document”). Background The aim of this guidance document is to enable marketing authorisation holders (“MAHs”) to submit post-authorisation applications which are in conformity with applicable
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was adopted and entered into force in 2014. The European Medicines Agency (“EMA”) has recently confirmed that the Agency is currently on schedule to introduce the new related EU portal
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines. Public quality standards form part of the regulatory framework governing the quality of all medicines. Both documentary and physical standards exist to ensure that medicines are of acceptable quality for use by
On December 29, 2016, FDA issued a new draft guidance regarding drugs and biologics entitled “Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information.” 81 FR 96013 (Dec. 29, 2016). The guidance provides an overview of the requirements for a valid electronic submission of manufacturing establishment information (MEI) under section 745(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce delays in processing applications. The MHRA is required to grant or refuse applications for manufacturing authorisations within 90 days of receiving a completed application. The
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of advanced therapy medicinal products (“ATMPs”) to meet patient needs (“the ATMP conference”). Background The aim of the ATMP conference was to discuss initiatives to improve advanced