European Regulatory Watch

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.

The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.

The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.

The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.

The repercussions of EMA’s relocation and Brexit will continue to be the dominant regulatory issue throughout 2018.

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.

The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.

EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.

The agency is asking public consultation on the concept paper.

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.

Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.

Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.

How involved should HTA bodies be in assessing cost effectiveness and reimbursements?

Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.

The pharmaceutical industry now braces itself for the consequences and complexities that could follow in the wake of the United Kingdom’s decision to leave the European Union.

The impact of pharmaceutical manufacturing on the environment has triggered demands for tighter environmental controls in EU and national legislations.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.

The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.