Pharmacy compounding is one of the topics in the EU Pharma Law Package that has perhaps received less attention compared to topics such as regulatory exclusivity rights, shortages, and sustainability. The EU Pharma Law...more
The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more
On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more
The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more
In the Netherlands, the Central Committee on Research Involving Human Subjects (CCMO) recently published a guideline to clarify the requirements applicable to interventional studies with humans in the context of food,...more
As of 18 June 2024, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency (EMA) apply, and will impact patients, health care professionals and sponsors. Also as of 18 June, a revised version of the...more
On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) “EU Pharmaceutical Law...more
On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been authorized under the Clinical Trials...more
Clinical trials in the European Union (EU) that were approved under the former EU Clinical Trials Directive (CTD) will soon need to transition to the current EU Clinical Trials Regulation (CTR). Sponsors and other impacted...more
Recent European Commission (Commission) proposals, including a broadening of the so-called ‘Bolar exemption’, would substantially change various incentive schemes related to medicinal product approvals, with the stated goal...more
On 24 October 2023, the European Commission (EC) adopted a set of actions in order to prevent and mitigate critical medicine shortages in the European Union (EU) this winter and beyond....more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more
With a goal of ensuring medicinal supply interruptions are better managed, the Dutch Ministry’s Policy Rule regarding ‘iron stock’ sets obligations for marketing authorisation holders and wholesalers to keep a minimum safety...more
The first module of the European database on medical devices, EUDAMED, also referred to as the Actor registration module, will be made available to EU Member States and economic operators on 1 December 2020....more
In addition to guidance issued by European Union (EU) Member States on the conduct of clinical trials during the COVID-19 pandemic, harmonized EU guidance has now been issued. On Friday, March 20, the European Commission, the...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
Digital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU....more
11/25/2019
/ 21st Century Cures Act ,
Data Management ,
Data Security ,
Digital Health ,
EU ,
Health Care Providers ,
Health Information Technologies ,
Information Technology ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry
The European Commission is looking into several parallel imports cases, including in the life sciences industry, with a view to opening formal antitrust investigations, which may eventually lead to fines being imposed....more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum
By Hein van den Bos, Ruth Franken and Silvia Gardini After months of discussion, a final vote has been cast on the European Medicines Agency (EMA)'s new home post-Brexit. And it's right around the corner from us, here in...more
11/21/2017
/ Biotechnology ,
EU ,
European Medicines Agency (EMA) ,
Life Sciences ,
Member State ,
Netherlands ,
Pharmaceutical Industry ,
Referendums ,
Regulatory Agencies ,
Regulatory Oversight ,
UK ,
UK Brexit
The EMA is looking for a new home. According to the Dutch Minister of Foreign Affairs and the Minister of Health, Welfare and Sports' formal bid, this home is where the heart of the Netherlands is. It might not have the food,...more