Harmonising and competing for medicines regulation: how healthy are the European Union's systems of drug approval?

Abraham, John; Lewis, Graham

doi:10.1016/s0277-9536(99)00042-8

Cited by 46 publications

(23 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The majority of registered drugs falls into Biopharmaceutics Classification System (BCS) class II (high permeability, low solubility) or IV (low permeability, low solubility) 8,9 . For the BCS class II drugs, the oral absorption is mostly limited by the solubility and/or dissolution in the gastrointestinal (GI) tract.…”

Section: Class IImentioning

confidence: 99%

Bioavailability and Bioequivalence Study in Correlation of Biopharmaceutics Classification System (Bcs) and Possible Modification

Kshirsagar¹,

Shikare²,

Shaikh³

2013

J Pharm Sci Innov.

View full text Add to dashboard Cite

In the last decade, the regulatory bioequivalence (BE) requirements of drug products have undergone major changes. Now a day the bioavailability and bioequivalence study is emerging area in the generic world. Today, the discovery of drug substances with increasing lipophilicity and resultant poor aqueous solubility is a more and more common problem in the development of orally administered new formulations. The Biopharmaceutics Classification System (BCS) is the technique used to differentiate the drugs on the basis of their solubility and permeability is a guide for predicting the intestinal drug absorption. The knowledge of the BCS characteristics of a drug in a formulation can also be utilized by the formulation scientist to develop a more optimized dosage form based on fundamental mechanistic, rather than empirical, information. The possible changes in the class three and four drugs we increase the solubility and permeability and achieve great success in the field of generic market. Here in this review we compile the information on all four class drugs of BCS and their possible modification.

show abstract

Section: Class IImentioning

confidence: 99%

Bioavailability and Bioequivalence Study in Correlation of Biopharmaceutics Classification System (Bcs) and Possible Modification

Kshirsagar¹,

Shikare²,

Shaikh³

2013

J Pharm Sci Innov.

View full text Add to dashboard Cite

show abstract

“…The differences in evaluation processes among nations therefore continue to be relevant. In studying EU harmonization, Abraham and Lewis (1999) found that national agencies compete for the industry fees (associated with product reviews) based on the speed of their approvals, which suggests a leveling downward of safety standards in the decentralized process.…”

Section: The Political Context In Britain and Francementioning

confidence: 99%

Emergent Patterns in the Regulation of Pharmaceuticals: Institutions and Interests in the United States, Canada, Britain, and France

Wiktorowicz

2003

Journal of Health Politics, Policy and Law

View full text Add to dashboard Cite

Although industrialized nations regulate pharmaceuticals to ensure their safety and efficacy, they balance these concerns with those related to the timeliness of the approval process and the burdens involved in meeting regulatory criteria. The United States, Canada, Britain, and France have adopted different approaches to the regulation of pharmaceuticals that place varying emphases on these competing goals and involve the participation of private interests to different extents. The regulatory approval processes and the government-industry relationships inherent within them are compared in the United States, Canada, Britain, and France by analyzing five features that distinguish the U.S. pluralist from the European corporatist approaches to policy development: representation (internal versus external), process (closed versus open), stance (informal, accommodative versus formal, adversarial), institutional power (fragmented versus centralized), and resources. An institutional framework further characterizes these approaches as based on models of managerial discretion and adjudication (United States), consultation (Canada), and bargaining (Britain, France) to clarify the patterns that emerge. While the approach that most effectively supports product safety involves managerial discretion as occurs in the United States, formal mechanisms for negotiation might be incorporated rather than a reliance on the judicial process. In an era of globalization and regulatory harmonization such divergence has significant implications. First, where harmonization in Europe involves the mutual recognition of one country's product licensing decision by the others, differences in evaluative processes remain important. Second, as harmonization leads to a common set of regulatory criteria, the criteria adopted tend to be those of nations with the least stringent regulatory standards, making evident the need for more responsive systems of post-market surveillance to protect the public interest.

show abstract

“…GMP). Abraham and Lewis, 18 in a study whose particular focus is the aws in the EU's system for harmonization of pharmaceuticals regulation, found that some regulators had concerns about trusting entirely to data submitted by companies. In principle, the same risks apply in the eld of biologicals, but in practice there are diÚ erences that attenuate the risk.…”

Section: Devolution To Industrymentioning

confidence: 99%

The Changing Landscape of Regulatory Control of Biological Medicines

Morris¹

2001

Technol. Anal. Strat. Man.

View full text Add to dashboard Cite

T his paper focuses on the rapid growth in biological medicines in recent years brought about by advances in molecular biology and biotechnological manufacturing techniques. It looks at the implications for regulatory bodies and research institutions concerned with quality control of biologicals; and discusses ways in which the industry/regulatory/research partnership is evolving in response to the new situation. It argues that, although change is being managed relatively successfully in some areas of regulatory control (devolution to industry, use of new technologies, international harmonization), special measures may be needed in some other areas. These include: needs of the developing world for biologicals quality control; sustaining long-term research on safety issues and test methodology; major social and ethical issues raised by new treatment and diagnostic opportunities.

show abstract

Harmonising and competing for medicines regulation: how healthy are the European Union's systems of drug approval?

Cited by 46 publications

References 4 publications

Bioavailability and Bioequivalence Study in Correlation of Biopharmaceutics Classification System (Bcs) and Possible Modification

Bioavailability and Bioequivalence Study in Correlation of Biopharmaceutics Classification System (Bcs) and Possible Modification

Emergent Patterns in the Regulation of Pharmaceuticals: Institutions and Interests in the United States, Canada, Britain, and France

The Changing Landscape of Regulatory Control of Biological Medicines

Contact Info

Product

Resources

About