Latest Posts › Pharmaceutical Industry

Share:

Market Access in Europe: Navigating Pricing & Reimbursement Pathways

In Europe, the regulation of pricing and reimbursement for medicinal products is primarily governed by national policies, as EU-level regulation is limited. Our latest brochure “Market Access in Europe: Navigating Pricing &...more

Pharmacy compounding under the EU pharma law package

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

Medicines shortages under the EU pharma law package

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

EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

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

EMA’S NEW WORK PLAN: Leveraging data and AI to encourage innovation and research

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

Panelists discuss European pharmaceutical trends and how to stay ahead of the game - Life Sciences and Health Care Horizons event...

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

New transparency rules for EMA’s Clinical Trials Information System (CTIS) - Clinical trial data disclosure in the EU

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

Reduction of EU regulatory data protection, but not as short as the European Commission proposed - European Parliament’s position...

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

Transition soon to the EU Clinical Trials Regulation

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

JPM2024: transactional considerations in view of a (proposed) broader Bolar exemption in EU

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

日本企業を取り巻くAPACライフサイエンス産業において、ゼネラルカウンセルが注目する重要課題についてパネリストが議論

2023年10月4日に東京事務所にて開催された「ライフサイエンス・サミット」では、ホーガン・ロヴェルズのライフサイエンス・ヘルスケア分野のアジア太平洋(APAC)リードであるフレデリック・チェン博士(東京事務所代表パートナー)、メリッサ・ビアンキ(ワシントンDC事務所パートナー)、ペニー・パウウェル(ロンドン事務所パートナー)、カレン・テイラー(ノーザンバージニア事務所パートナー)、へイン・ファン・デン・ボス(アムステルダム事務所パートナー)が、...more

European Commission steps to safeguard medicine supply in the EU

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

Horizons 2023: Panelists discuss key issues keeping APAC life sciences GCs up at night

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Tokyo, where Hogan Lovells Tokyo office managing partner and Asia-Pacific (APAC) lead for the Life Sciences and Health Care...more

Panelists discuss how European pharmaceutical companies can stay ahead of the game

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

Successful product launches across the EU, UK, and U.S.

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

Medicines shortages: Dutch Ministry publishes Policy Rule; EMA calls for MAHs to register contact

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

Medical devices in the EU - Update on EUDAMED database: The first module is here!

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

Highlights from the DigiHealth Leaders Conference: interoperability, reimbursement, patient centricity, and forging effective...

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

Life Sciences and Health Care Horizons - 2019

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

Regulatory Insights for Life Sciences and Health Care Investments: Regulatory changes in Europe

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

The European Commission Is Considering Opening an Antitrust Probe for Parallel Imports in the Pharmaceutical Sector

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

Understanding sunshine rules: how new transparency regulations in Europe are changing relationships between industry and health...

The 2010 Physician Payments Sunshine Act created a new standard of transparency for financial relationships between pharmaceutical companies and health care professionals in the U.S. Now, countries across Europe are following...more

EMAmsterdam: Hogan Lovells welcomes its new neighbour

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

26 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide