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Analysis of the Authorized Target Populations for Fixed Dose Combination Products Between 2000 and 2017 Reveals Discrepancies Between EMA’s and FDA’s Views on Initial Dual-Therapy
Background:A fixed dose combination (FDC) product containing two components can be authorized for the use in 3 conceptual scenarios (1) as...
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An Update on the Registration of Biosimilars in Malaysia
BackgroundBecause of its structure and complex manufacturing process, every biotherapeutic product (BTP; medicinal products made by or derived from...
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Practical Issues of Preclinical Pharmacokinetic Investigations of New Drugs (Review)
Several issues with pharmacokinetic studies of new drugs, in particular, experiment planning, development of study protocols, dose selection, and...
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The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System
BackgroundThe aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and...
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A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways
Background:As regulatory agencies come under increased pressure to review medicines of critical importance through efficient regulatory systems to...
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Providing added value to local uses of paparahua (Artocarpus altilis) in Amazonian Ecuador by phytochemical data review
Artocarpus altilis (Parkinson ex FAZorn.) Fosberg, Moraceae, is a native tree of Southeast Asia introduced to South America at the beginning of the...
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Current Requirements for Assessment of Elemental Impurities (Heavy Metals) in Medicines
One element of ensuring the quality and safety of medicines consists of normalizing and controlling elemental impurities (heavy metals). The sources...
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Optimized Medical Product Regulation in Mexico: A Win-Win for Public and Economic Health
BackgroundMedicines regulators, while performing a vital public health activity, are often perceived as both negative cost centers for governments...
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Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access Strategies
Swee** reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign...
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Import Testing: An Outdated Practice? Opportunities for Improved Access to Safe and Efficient Medicines
Import testing of medicines is performed in the middle of the legitimate supply chain when a product enters a country. Risks, however, are identified...
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The Common Pharmaceutical Market of the Eurasian Economic Union: A Regulatory Review
According to the Treaty on the Eurasian Economic Union, a common pharmaceutical market was supposed to become operational on January 1, 2016....
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Best Practices for Submitting Promotional 2253 Submissions in the New Module 1 Specification
June 2016 marks 1 full year since the optional implementation of US Module 1 Specification v2.3. Since its release, pharma companies have dealt with...
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Accelerated Pathways Work—Now What? A Survey of Payers in the United States
BackgroundThe US FDA has developed numerous accelerated pathways (APs) to facilitate faster development and approval of innovative drugs addressing...
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Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap
The value of patient involvement (PI) in medicines research and development (R&D) is increasingly recognized by all health stakeholders. Despite...
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Quality Assessment of Excipients at the Drug Registration Stage
Amendments to Federal Law No. 61-FZ “On Circulation of Medicines” of April 12, 2010, come into force on January 1, 2016, and extend the requirements...
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Regulatory System Changes in Russia: A Historical Review and Future Perspectives
The Russian pharmaceutical market is expected to grow and attract foreign investors. Nevertheless, the frequent changes in regulatory legislation...
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Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation
The challenge of providing access to high-priced patented medicines is a global problem affecting all countries. A decade and a half ago the use of...
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Comparative Analysis of Quality Assessment Requirements for Gelatin Used in Drug Production (Review)
Gelatin is usually used as an excipient in drug preparations and more rarely as an active ingredient. Domestic quality standards regulating gelatin...
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Assessing the Quality of Decision Making in the Development and Regulatory Review of Medicines: Identifying Biases and Best Practices
Background: Although the quality of decision making (QDM) in the development and regulatory review of medicines influences the delivery of new...
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Pharmaceutical Policy in South Africa
South Africa has implemented a number of important medicine policies in the post-apartheid era, informed by the 1996 National Drug Policy. Despite...