Regulatory/GMP Compliance, Europe

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.

This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.

EC has granted marketing authorization approval to Roche for Tecentriq (atezolizumab), in combination with chemotherapy, as a first-line treatment for patients with extensive-stage small cell lung cancer.

EMA has started a data review of Picato (ingenol mebutate) to investigate the potential for skin cancer risk.

Roche revealed that the European Commission has approved the combination of Tecentriq (atezolizumab) with Abraxane for the treatment of adult patients with PD-L1-positive, metastatic triple-negative breast cancer.

EMA is seeking ways to improve the effectiveness of its PRIME scheme, so that scientific innovations and new technologies more readily lead to novel medicines.

Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.

Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

EMA issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

Joint analysis from the EMA and the US FDA has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.

Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.

European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.

Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.

Much has changed in the bio/pharma industry over three decades. In this special feature, the editors take a trip down memory lane, highlighting some of the major happenings of the past 30 years.

Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.

CHMP and CMDh have recommended that all marketing authorization holders (MAHs) of medicines containing liposomal drug delivery systems change the medicine name to avoid medication errors.

EMA has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant.

MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.

As drug supply chain security is of paramount importance, could radio-frequency identification solutions provide the optimal solution for pharma companies?

MHRA has issued a drug alert for the Emerade adrenaline auto-injector device, as a result of the device’s potential to fail in delivery of the dose due to blockage of the needle.

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

Patient consent is potentially tricky for pharma R&D to navigate as a result of new data protection rules in Europe.

CHMP of the European Medicines Agency has recommended a change to the European marketing authorization for AstraZeneca’s Forxiga (dapagliflozin) in patients with Type-2 diabetes.