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Category Archives: Pharmaceutical & Biotechnology

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New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

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[1].  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

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

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

UK to Seek Close Relationship with EMA Post-Brexit

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

Just in Time: FDA Finalizes Guidance on Assessment of Abuse Potential of Drugs

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

What’s ahead with the new Trump administration?

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?

EMA Update concerning EU Clinical Trials portal and database

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

UK MHRA to develop quality standards for biological medicines

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

FDA Clarifies Requirements Regarding Submission of Manufacturing Establishment Information

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).

UK MHRA publishes “top tips” for manufacturing authorisation applicants

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

EMA on optimising the development of advanced therapies

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

EMA hosts workshop on adaptive pathways

On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach. The aim of the workshop was to gather stakeholder feedback in light of the practical experience gained during the adaptive pathways pilot project EMA

Scottish government to reform approval process for new end-of-life and orphan medicines

The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients in Scotland, published in a report on 14 December 2016. The recommendations aim to further improve the process by which these types of medicines, in particular ultra-orphan products,

Japan considering drug-pricing reform

At the instruction of Prime Minister Shinzo Abe, Japan’s Council on Economic and Fiscal Policy has begun to draw up a basic policy on drug pricing, based on which the Japanese government will start to reform the country’s prescription drug pricing system.

Revisions to Clinical Data Publication Guidance extends scope of EMA disclosure power to clinical data submitted before 1 January 2015

On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use (“Policy 0070”) and revisions to the guidance to industry. Among the new elements introduced

Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act

Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60 calendar days after the date of enactment to publicly post their expanded access (EA) policies for individual patient access. This deadline falls on February 11, 2017. For new investigational drugs, this provision applies upon initiation of a Phase II or Phase III study for that drug.

New Belgian Innovation Office to Accelerate Availability of Novel Medicines

In July 2016, the Belgian Agency for Medicines and Healthcare Products (“FAMHP”) took steps to establish a National Innovation Office as part of the European Union (“EU”) Innovation Network. The National Innovation Office is currently being established by the FAMHP. It is expected to become functional in the first quarter of 2017. The National Innovation

Commission opens public consultation on the EU Paediatric Regulation

On 15 November 2016, the European Commission (“the Commission”) opened its second report on Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use, as last amended (“the Paediatric Regulation” or “the Regulation”) for public consultation. The consultation deadline for the draft report

21st Century Cures Offers More Latitude to Promote Health Care Economic Information, but Ambiguities Would Remain

Last Wednesday, the U.S. House of Representatives passed the 21st Century Cures Act , the culmination of an extensive, multi-year effort by the House Energy and Commerce Committee to develop this sweeping legislation. The 21st Century Cures Act now faces a vote in the Senate, likely within days.  The White House has already expressed support for

New Rule Amends FDA’s Citizen Petition Regulations to Implement Section 505(q) of the Food, Drug, and Cosmetic Act

The U.S. Food and Drug Administration (FDA) has issued a final rule implementing section 505(q) of the Federal Food, Drug, and Cosmetic Act (FDCA).  Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets, 81 FR 78500 (Nov. 8, 2016). Congress enacted 505(q) with the purpose of ensuring that

EMA revises Guideline on First-in-Human Trials

On 15 November 2016, the European Medicines Agency (“EMA”) opened for public consultation its updated Guideline on strategies to identify and mitigate risks related to first-in-human and early clinical trials with investigational medicinal products. The EMA has revised the Guideline, in cooperation with the European Commission and the EU Member States, to further improve the

Ninth Research Framework Programme (FP9) in preparation

The current eighth European Union Research, Technological Development and Demonstration (“RTD”) Framework Programme, entitled Horizon 2020, will expire on 31 December 2020. On 12 October 2016, the Director General for Research and Innovation announced that the European Commission is currently starting to work on and plan for the ninth RTD Framework Programme (“FP9”) which will