A leader from Medicines for Europe will share with CPhI Worldwide attendees a look at medicine production and offer solutions for elevating the industry.
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
Scientist.com is working to implement an improved contractual landscape ahead of GDPR implementation in May, in order to ensure global compliance among sponsors and CROs.
The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies filed to suspend the release in 2016.
Eurodis says Brexit-related costs and admin burden placed on UK pharma may affect availability of drugs for rare diseases and discourage development of such products.
The European Commission has publish a draft revision of its GMP guidelines on the production of sterile drugs with tweaks to recommendations on clean rooms, sealing technologies and single-use systems.
UK regulators have banned Apotex Research Private Limited from shipping drugs made at its plant in Bangalore, India to the EU after inspectors raised concerns about the potential for cross contamination.
Identifying dangerous medicines will take months longer if the UK cannot negotiate continued involvement in EU drug safety and health monitoring say industry groups.
UK regulators have issued Bangladesh-based drug maker The Acme Laboratories Limited a statement of GMP non-compliance after finding a plant inspection.
The UK government has outlined its industrial strategy as it prepares to leave the European Union and boasts of investments and collaborations driving the life science sector.
European member states have selected Amsterdam as the post-Brexit home of the European Medicines Agency, following a secret ballot vote in Brussels yesterday.
The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.
Clinical trial sponsors plan to release more trial results summaries over the next year as part of patient engagement efforts, according to a recent survey.
Generics industry group Medicines for Europe says proposed supplementary protection certificate (SPC) waiver will help European API manufacturers compete.
Irish regulators say it is still not clear how Brexit will affect companies that make drugs in the UK, raising issues like MA status and mutual inspection agreements between the EMA and US FDA as areas of concern.
The European Medicines Agency (EMA) has announced it will launch an updated version of information system EudraVigilance to better monitor suspected adverse reactions to medicines.
Gene therapy developers should start planning earlier, as EU GMO regulations are delaying clinical trial start-up across the bloc, according to a new expert position paper.
CMO PR agency ramarketing has secured investment to set up a US base in a bid to attract North American contractors interested in accessing the complex European market.
Post-Brexit relocation will, at best, delay approvals and, at worst, limit drug availability and put European patients at greater risk of side effects and death according to the EMA.
The EMA has asked the European Ombudsman for concrete details of its probe of pre-submission activities, warning that Brexit preparations have limited its capacity to respond.
AstraZeneca has said it will wait to see how Brexit negotiations progress before deciding whether to make mid-to-large scale manufacturing investments in the UK.
Science Exchange has been certified under the EU-US Privacy Shield Framework after completing a seven-step process to demonstrate compliance with various data protection requirements.
Adents has become an official Certified Gateway Provider following a series of tests with the European Medicines Verification Organization (EMVO) ahead of the EU Falsified Medicines Directive (FMD).
UK patients face drug shortages unless Tory Government Ministers negotiate an orderly withdrawal from the EU – Brexit – that safeguards existing approvals and continued regulatory cooperation according to pharmaceutical industry groups.
The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.
A directive granting Belgium, Greece and Italy a six-year reprieve in serialisation adoption has raised concerns delayed implementation could be an opportunity for drug counterfeiters.
German Merck and Sigma-Aldrich broke EU merger procedures and could face a fine equivalent to 1% of the combined firm's annual revenue according to the European Commission
NGOs have criticised the European Commission’s plan to combat antimicrobial resistance (AMR), saying the policy does not adequately address environment contamination concerns.
The European Commission has confirmed that UK drug ingredient manufacturers will have to supply European customers with written confirmation their products are made in compliance with EU standards after Brexit.
European regulators’ efforts to develop continuous manufacturing guidelines are not as advanced as their US counterparts according to delegates who attended a conference last month.
Italian regulators say Kores Limited’s facility in Roha, India should be banned from supplying the API ambroxol hydrochloride to the EU and advised users to find an alternative source.
The European Commission has urged UK Pharma firms to check how Brexit will impact their drugs, pointing out that EU law requires that authorisation holders have a base in a member state or EEA country.
LabCorp will relocate its UK CMC services unit to a larger site and has said it is confident the Government will maintain its commitment to the drug industry after Brexit.
Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the MHRA limit communication to essential information.
The EMA has launched a technical anonymization group (TAG) that will help it develop best practices for clinical report anonymization following recent policy changes.
The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.
Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
The EU and US have agreed to recognize drug and API manufacturing plant inspections conducted in their respective territories under a deal signed this week.
