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The article presents the new regulatory guidelines related to the U.S. Food and Drug Administration (FDA), International Conference of Harmonisation (ICH) Manufacturing, and European Medicines Agency (EMA) that was issued on June 2011 to May 2012 including size of beads in drug products, direct-to-consumer television advertisements, and DNA vaccines.

The article discusses regulatory aspects transition from clinical to commercial supply chain in the pharmaceutical industry. It states that challenges faced in selection of drug substance regulatory starting materials (RSMs), and mentions the emphasis during pharmaceutical development on the portion downstream of the RSMs. It notes that the European Medicines Agency (EMA) published a reflection paper on the requirements for selection and justification of starting materials.

The article discusses the innovative approaches used by pharmaceutical companies to improve patient experience and patient outcomes in taking their medication. Guidance documents encouraging pharmaceutical companies to design products that promote patient compliance and reduce medication errors has been issued by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The article lists several manufacturing guidelines of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) that issued in 2013 including the FDA Draft Guidances, the EMA Draft Papers and the FDA Final Guidances.

The article focuses on the emergence of advanced manufacturing technology in the biopharmaceutical industry, indicating a shift toward distributed manufacturing models. Topics discussed include the U.S. Food and Drug Administration's recognition of the need for flexible manufacturing, regulatory challenges, and the potential of point-of-care (POC) manufacturing to address issues such as drug shortages and pandemic preparedness.

The article discusses nanomedicines in context of regulatory difficulties faced. It informs that nanomedicines have been authorized by the European licensing agencies for more than 30 years. It states that safety rules on nanosubstances in medicinal products in Europe are perplexing because nanotechnologies are applied to drug-delivery systems, carriers, and imaging agents. It states about reflection papers of the European Medicines Agency (EMA) on nanotechnologies.

The article focuses on the regulatory issue and concerns on data integrity in good manufacturing practice (GMP)-regulated laboratories. Topics discussed include the focus of inspection on electronic records and computerized systems, the non-compliance to European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), and the use of laboratory information management system (LIMS) for data management and documentation.

The article focuses on the debate of regulatory officials about the methods for producing water for injection (WFI) in Europe. It highlights the concerns of the European Medicines Agency (EMA) about reverse osmosis, including biofilm, bacterial endotoxins and microbial fouling. It notes the essence of the harmonization of requirements in giving pharmaceutical manufacturers a choice of technologies for producing WFI.

The article focuses on the importance of project management in the pharmaceutical industry to promote drug approvals by government agencies following the decline in the number of drugs approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Topics include guides for the promotion of project management in drug development, the benefits offered by effective pharmaceutical projects, and the role played by a project management office (PMO) in a company. INSET: BEST REGULATORY PRACTICES FOR MANAGING PROJECTS WITH....

The article explores the legislative framework of alcohol-induced dose dumping (ADD) for modified-release formulations. Topics discussed include revolutionalization in the delivery of active pharmaceutical ingredient APIs using modified-release (MR) systems, use of polymer matrix or by a polymer film coating for controlling drug release and need for harmonization of the U.S Food & Drug Administration FDA and European Medicines Agency EMA guidelines concerning ADD in-vitro testing conditions.

The article discusses effective cold-chain practices in pharmaceutical industry to protect blood products and vaccines from damage. It also informs about controlled room temperature (CRT) products which are maintained at 15-25 degree celsius for ensuring quality and efficacy. It informs that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are collaborating for good cold-chain practices. INSET: Anticounterfeiting technologies: tools to combat counterfeiters.

The article focuses on issues related to labeling of biosimilars that are needed to be addressed by the European Medicines Agency (EMA). It mentions that the EMA's biosimilar labeling is based on 2012 guidelines which states that biosimilar's summary of product characteristics has to be derived from those of the reference product. It informs that the European Biopharmaceutical Enterprises and European Association of Bio-industries claim that biosimilar labeling is similar to generic medicines.

The article discusses the decision of the European Medicines Agency (EMA) to collaborate with EUnetHTA, a European Union (EU) health technology assessment (HTA) network, in giving advice to pharmaceutical manufacturers in the early stages of the development of new medicines in 2014. Information on the impact of HTAs on biosimilars is provided. Also discussed are the issues on the selection of biosimilars in some European countries.

The article focuses on the shortage of drugs in Europe that has resulted in problems to health services. It discusses the reasons of drug shortage including globalization, few manufacturing sites and financial pressure from low generic drug prices. It focuses on the steps taken by European Medicines Agency (EMA) for limiting the drug shortage which include setting regulatory measures, developing risk-ranking methodology, decision making with stake holders.

The article focuses on the efforts of the European Union (EU) authorities for the quality-by-design (QbD) principles' incorporation in their guidelines and regulations. It says that the European Commission (EC) and the European Medicines Agency (EMA) have been pressured by the pharmaceutical industry to promote QbD's adoption. It adds that Europe's pharmaceutical industry believes that introducing the QbD concepts in the guidelines and rules stresses the important quality assurance elements.

The article offers news brief related to pharmaceutical industry as of January 2013. It mentions that European Medicines Agency (EMA) has declared for early notification from pharmaceutical industry related to production problems. Several academics and companies including F. Hoffmann-La Roche Ltd., University of Oxford and Innovative Medicines initiative (IMI) has signed to work on stemBANCC project. It informs that investment prices in specialty drugs have rose prices of branded drugs.