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RAPS in Europe

RAPS & Regulatory

RAPS is the leading international membership organization for regulatory professionals who are working to ensure the safety, effectiveness and availability of healthcare products, including medical devices, pharmaceuticals and biotechnology. We are dedicated to advancing the profession and providing the highest level of support, knowledge, direction and standards to the regulatory community. Together we are making better healthcare products possible.

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Conferences & Events
News

EU Court Backs Longer Patent Protection for Multidisease Drugs
December 2011
The EU's highest court supported extended patent protection for drugs and vaccines effective against multiple diseases. Read more »
European Medicines Agency to Revise Biosimilars Guideline
December 2011
The European Medicines Agency is planning to update its guideline on biosimilars, which went into effect in 2005. Read more »
European Commission Consults on Unique Identifiers for Medicines
December 2011
The European Commission is considering new pharmaceutical packaging elements to prevent counterfeit drugs from entering the supply chain. Read more »
UK Drug Supply Shortages Dispute Continues; Health Minister Makes Statement
December 2011
UK Health Minister Simon Burns argues to the House of Commons that the existing system of best practice guidance is a better option for addressing drug supply shortages than introducing mandatory supply regulations. Read more »
Russian Health Protection Bill Ratified
December 2011
Russian President Dmitry Medvedev has signed a bill that makes fundamental changes to the country's healthcare system and impacts pharmaceutical regulation. Read more »
EU sets out Tough Rules on Medicines Information
November 2011
The newest proposals by the European Commission will restrict the ways drug manufacturers can provide information on prescription-only medications to consumers. Read more »
European Court Ruling 'Threatens Stem Cell Work'
November 2011
The European Court of Justice has decided that the use of embryonic stem cells in scientific research cannot be patented. Read more »
EU Defines Nanomaterials in Bid to Assess Health Risks
November 2011
The EU has issued a definition of nanomaterials to assist regulators in discerning their presence in consumer goods and food. Read more »
Pressure Grows on Drugmakers to Reveal R&D Returns
November 2011
Dissatisfied shareholders are pushing drug manufacturers to increase the transparency of internal return rates for investments into research and development. Read more »
Europe's Smaller Drug Firms Feeling Pain
November 2011
Small to midsize drugmakers that derive much of their revenue from Southern Europe's state-funded healthcare systems are being adversely affected by the region's debt crisis. Read more »
EU Regulations Hindering Drug Development, Say Charities
October 2011
Overly burdensome regulations are impeding the progress of developing new, potentially life saving drugs, according to a group of charity organisations. Read more »
Drugmakers to Delay Launching New Drugs
October 2011
A trio of multinational drugmakers have called off plans to launch new drugs in Germany due to new requirements to negotiate the prices of new drugs based on cost-effectiveness criteria. Read more »
European Union: EU Court to Clarify Medical Device/Drug Distinction
October 2011
A clarification of the EU law regarding the distinction between the medical devices and medicinal products industries is currently being developed at the European Court of Justice. Read more »
Drug Firms Using Backdoor Tactics to Boost Sales, Says Report Reveals
October 2011
A study shows that many central and eastern European drug companies are using backdoor lobbying and payments to prominent doctors and patient groups to ensure governments buy their medications. Read more »
Diagnosia Aims to Provide European Drug Search Engine
October 2011
Diagnosia is looking to provide a pan-European drugs database for doctors and patients to enable them to simply and quickly compare drug prices in 22 different markets. Read more »
EFPIA Backs Move Toward Full Clinical Data Transparency
September 2011
The European Federation of Pharmaceutical Industries and Associations (EFPIA) thinks that in the future, virtually all data from relevant clinical trials should be disclosed once a new medicine receives approval for marketing. Read more »
ESC Calls for Overhaul of CE Mark for Medical Devices
September 2011
The European Society of Cardiology is calling for an overhaul of Europe's CE mark scheme as it relates to the assessment and approval of new medical technology. Read more »
France to Reform Pharmaceutical Industry Regulation
September 2011
The growing importance of communicating product value will make dialogue between firms, regulators and payers increasingly common in France. Read more »
Drugmakers Agree on New Standard for Describing a Compound’s Effects
September 2011
Representatives of pharmaceutical companies, data resource providers and academic groups have agreed on a new standard for describing a compound's effects on a biological entity. Read more »
Spanish Doctors Told to Prescribe Cheaper Generic Drugs
September 2011
The Spanish government has passed a new law requiring doctors and pharmacies to prescribe generic drugs instead of more expensive brand names, a move that could save €2.4 billion per year. Read more »
EU Plans Review of Ban on Drugmakers’ Direct Communications With Patients
August 2011
The European Commission has announced plans to review its limits on drug companies communicating directly with patients and publish new draft rules. Read more »
FDA, EMA Collaborating to Create Harmonised Biosimilars Review Path
August 2011
FDA and EMA have agreed to cooperate on harmonising biosimilars regulations, which could help FDA catch up in its development of an abbreviated path for approving follow-on biologics. Read more »
EU Updates GDP in Line With Falsified Medicines Directive
August 2011
A new draft guideline from the European Commission on Good Distribution Practice for drugs is out for public comment until 31 December. Read more »
Advocate General Issues Opinion on Patent Extensions for Medicinal Products
August 2011
The European Advocate General recently delivered an advisory opinion on questions regarding the conditions for obtaining supplementary protection certificates for medicinal products marketed in EU Member States. Read more »
Entered Into Force: New Rule to Improve the Safety of Electronic Products
August 2011
On 21 July, a new EU rule went into effect, banning the use of heavy metals and other dangerous chemicals in electrical and electronic equipment and a variety of other products. Read more »
Clinical Trials Environment Declining
July 2011
Despite the extensive network of clinical trials units across the country, the UK is losing its leadership edge in the competitive market for conducting clinical trials. Read more »
EMA Publishes Details of New Pharmacovigilance Format
July 2011
EMA has published the electronic formats in which pharmaceutical firms will have to submit information on medicines authorised or registered in the EU. Read more »
FDA Approves Cancer Drugs Faster, More Frequently Than EU
July 2011
FDA approves cancer drugs faster and in larger numbers than the EMA, according to a recent study conducted by Friends of Cancer Research, a think tank and advocacy organisation. Read more »
Traditional Chinese Medicines Hampered by EU Regulations
July 2011
Strict registration rules for Chinese medicines in the EU may hinder the use of traditional Chinese medicine in the region, reduce confidence in such medicine and lead to shortages at clinics, experts say. Read more »
The Nanomechanics Revolution in Medicine
July 2011
A new method based on nanotechnology could accelerate the discovery process for pharmaceutical products as well as diagnostic and therapeutic processes. Read more »
EU Doctors Call for Tougher Device Regulations
May 2011
A group of doctors from the European Society of Cardiology has raised concern over the EU’s oversight of medical devices and called for tougher standards. Read more »
GPs Given All Clear to Strike Price Deals With Drug Firms
May 2011
The Association of the British Pharmaceutical Industry’s revised code of conduct allows risk-sharing agreements between general practitioners and drug companies. Read more »
EU Probes ‘Pay-for-delay’ Deal on Sleep Drug
May 2011
EU antitrust regulators recently announced that they are investigating whether two drug manufacturers worked to prevent generic versions of a sleep-disorder drug from reaching the European market. Read more »
Healthcare: Left to Its Own Devices
May 2011
Johnson & Johnson has acquired Swiss orthopaedics company, Synthes, in a deal that reflects the growing trend toward consolidation of the $300 billion medical device industry. Read more »
European Parliament Questions Impartiality of EMA Experts
May 2011
The European Medicines Agency budget approval process stalled over concerns about breaches in the agency’s code of conduct. Read more »
Device Industry Pushes to Keep Decentralised EU Regulation
April 2011
In upcoming revisions to the EU's medical device directives, Eucomed is pushing for tighter Notified Body control, instead of moving away from the EU's decentralised regulatory approach. Read more »
EU Consults on Drug Pricing, Reimbursement Decisions
April 2011
The EC has started a public consultation regarding the modernisation of rules on the transparency of Member States' decisions in drug pricing and reimbursement. Read more »
Commission's Nano Policy Lost in Definition
April 2011
The EC's hesitance to define nanotechnology highlights differing opinions among stakeholders and is causing general uncertainty in the field. Read more »
EMA and FDA Announce Pilot Programme for Parallel QbD Assessment
April 2011
EMA and FDA have launched a three-year pilot programme for parallel evaluation of relevant quality data components, known as Quality by Design (QbD), of selected applications that are submitted to both agencies at the same time.Read more »
EMA to Drugmakers: Translate Product Info Into Croatian Before Accession
April 2011
In preparation for Croatia's entry into the EU, EMA is pushing Marketing Authorisation Holders of pharmaceutical products to translate all relevant information into Croatian. Read more »
EMA Launches EU Clinical Trials Register
March 2011
The European Medicines Agency (EMA) has launched its EU Clinical Trials Register, an online database that gives the public access to information on interventional clinical trials for medicines authorized in the 27 EU Member States and Iceland, Liechtenstein and Norway. Read more »
European Drugmakers Attack US Patent Plans
March 2011
An effort by the US government to bring cheaper generic drugs to the US market more quickly to help reduce healthcare costs is drawing criticism from the European pharmaceutical sector. Read more »
EU Trade Deal Could Cost Canadian Drug Plans Billions
March 2011
A new study warns that a trade deal being negotiated between Canada and the EU contains provisions that could add nearly $3 billion (Can.) annually in costs to Canadian drug plans. Read more »
FDA Challenges Medical Device Approval Comparisons With Europe
March 2011
The US Food and Drug Administration (FDA) recently defended its approval process for medical devices during a congressional hearing, arguing that comparisons with European approval methods are not appropriate. Read more »
Germany: Patent Term Extension for Medical Devices
March 2011
The first German patent term extension granted for a medical device, a combination product, may result in additional extended patent protection for combination products, creating new opportunities in product development. Read more »
Study: European Regulatory Regime Just as Safe as FDA's
February 2011
A study of medical device recalls in the EU suggests that regulators there are faster and just as effective as their counterparts at FDA. Read more »
Drug Firms Must Give Details on Patent Deals, EU Regulator Says
February 2011
EU antitrust officials recently told drugmakers to submit details on patent settlement deals that could be used to delay the sale of generic versions of medications. Read more »
EU Device Regulations Remain Fragmented When Compared With US
February 2011
Medical device regulations in the EU are still far more fragmented than in the US as device companies must deal not only with the European Commission, but also with a variety of national regulations and authorities. Read more »
France to Shake Up Medical Regulation
February 2011
France has promised to revise its medical regulations following a damaging report that exposed failures that resulted in the continued sale of a drug suspected of killing at least 500 people over 34 years. Read more »
New Agency Proposed to Approve Drug Clinical Trials in the UK
February 2011
To speed up the approval of drug trials, the UK Academy of Medical Sciences is recommending that the process be condensed and streamlined under a new independent agency. Read more »

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RAPS Europe

Located in Brussels, RAPS Europe supports RAPS programs, events and operations throughout Europe and serves as the RAPS’ base for European operations. Contact:

RAPS Europe
Tervurenlaan 300 Avenue de Tervueren
B-1150 Brussels, Belgium
Tel: +32 (0)2 740 22 38
Fax: +32 (0)2 743 15 50
rapseurope@raps.org

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