Strategies of Bringing Drug Product Marketing Applications to Meet Current Regulatory Standards (original) (raw)
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Post-approval changes are inevitable and necessary throughout the lifecycle of pharmaceutical products to implement new knowledge, maintain a state of control, and drive continual improvement. This One-Voice-of-Quality (1VQ) position paper is part of a series of industry case studies intended to demonstrate the standard application of the principles outlined in the publication “Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) Through Enhanced Science and Risk-Based Approaches Industry; One-Voiceof-Quality (1VQ) Solutions” in PDA Journal of Pharmaceutical Science and Technology, 2020 [1]. 1 Ramnarine et al.: post-approval changes Published by ARROW@TU Dublin, 2020 Level3 Issue 17, December 2020 Technological University Dublin 2 Furthermore, this 1VQ position paper provides a practical application of the concepts described in ICH Q9, Quality Risk Management [2], ICH Q10, Pharmaceutical Quality System [3], and ICH Q12, Technical and Regulatory Co...
STEPS TO BE FOLLOWED DURING REGISTARTION OF DRUG PRODUCT WITH CRITICAL PARAMETERS
Registration of a drug product is a vital task in the world countries. The quality , safety and efficacy plays an important role during the drug registration process. For better treatment, and also for the best safety and efficacy of the drugs must be maintained and rationalize for public security. The requirements of drug products are harmonized in regulatory countries by common technical document. The main step is to know the detailed study about the dossier. The quality, safety and efficacy has its own role in the dossier. ICH brought regulatory authorities and pharmaceutical industries of Europe, Japan and Us. This paper approaches with the critical parameters during drug product registration in the form of dossier.
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These days, finding new marketing authorizations, guaranteeing regulatory compliance, and keeping labour costs competitive are extremely tough. Many pharmaceutical companies also struggle to deal with local regulatory issues and stay up with changes in key pharmaceutical markets. Regulations are thoroughly reviewed before being given to the RA department. This team compiles the most critical prescription information for global approval and marketing. This category accepts both new and revised product submissions. This is mostly handled by the RA department. RA's job is to provide feedback on proposed or disputed legislation. This is a proactive measure. The ICH framework allows for more early intervention. Regulators have a wide range of responsibilities. In the US, the FDA must register and clear the goods with the export company's regulatory professional.
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A generic drug is more efficient, safe and low-cost alternative of the innovator or branded drug in the market. They are similar to the branded drugs in strength, quality, purity and their safety and efficacy have been proven since they have been in the market for a longer time. The availability of generic medicine should be made easier throughout the world. The US has one of the most demanding regulatory authorities and registration of drug products will be a long process if not complied with the US Food and Drug Administration (USFDA) guidelines. Abbreviated New Drug Application is the application to be filed for registering generic drug. One of the main tasks of the regulatory authorities is to ensure that the drug development, manufacture and testing has been carried out according to the regulations and guidelines and that everything is documented accordingly. International Conference on Harmonization (ICH) established a harmonized format for submission of application on registering drug products. This paper approaches the registration requirements of generic drugs in the form a dossier for market authorization in the US.
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"Global Regulatory Viewpoint" addresses various regulatory and compliance topics including newly-published regulations from a global perspective. The content in this column is intended to be useful to those who deal with pharmaceutical development, development of CMC dossier sections, and guidances for manufacturing, validation, and CGMPs. Reader comments, questions, and suggestions are requested. Readers are invited to submit manuscripts for publication in this column.
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Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts. They also increasingly have recognized that quality needs to be built into systems and processes throughout the lifecycle of the product. Moreover, the recent COVID-19 crisis has emphasized the need to adopt practices that better promote global supply chain resilience. In this paper, the USP Quality Advisory Group ...