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The document outlines the regulatory application process for pharmaceutical products in India. It describes the different types of applications including new drugs, variations, generics, and extensions. It lists the key application categories and types. The document also describes the dossier requirements including quality, safety and efficacy data. Finally, it outlines the 8 phases and milestones of the application review process from pre-submission to post-decision activities.
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![• Application :regulatory activity required in respect of a product:
• Application category :ex:, category 1 and category 2 applications
• Application Type:
• New chemical/biological entity, new salt/ester/isomer/complex/derivative of an existing active
ingredient, a similar biological medicinal product [A]
• New fixed combination medicine [B}
• Extension of indications [C]
• Generic medicine [D]
• Major variation (new dosage form, change/increase in patient group, change in dosage (eg.,
dosage amount, frequency of use or dose regimen), new strength, new route of
administration) [F]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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This document provides an overview of regulatory requirements for drugs and pharmaceuticals. It discusses drug regulation by international agreements and regulatory authorities like the FDA. The FDA is organized into centers responsible for drugs, biologics, devices and food. Applications like IND, NDA, ANDA are described which are required for investigational and approved drugs. The new drug approval process is outlined involving pre-clinical and clinical testing taking 10+ years. Key differences between NDA for new drugs and ANDA for generic drugs are summarized.
Arcs presentation-recent-tga-activities
The document provides an update on recent activities of the Therapeutic Goods Administration's Scientific Evaluation Branch. It discusses the launch of an electronic form for prescription medicine variations and notifications, as well as a comparable overseas regulator report-based process. It also covers work-sharing with international regulators, biological and biosimilar naming conventions, and reforms to the regulation of autologous human cells and tissues. Recent approval times for different drug categories are presented, along with the impact of stopping the approval clock in some cases. Efforts for continual improvement in evaluating generic medicines are also noted.
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The SUPAC guidelines provide recommendations for post-approval changes to NDAs and ANDAs, including changes to components, manufacturing processes, batch size, and manufacturing sites. The guidelines classify changes as minor (Level 1), moderate (Level 2), or major (Level 3) based on their potential effect on product quality and performance. Level 1 changes require chemistry and dissolution documentation, while Level 2 changes may also require in vivo bioequivalence testing or stability testing. Level 3 changes always require bioequivalence testing and prior approval before implementation. The guidelines aim to streamline regulatory processes for industry while ensuring safety and effectiveness.
Phases of clinical trials
Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of any new drug.
Supac guidelines for mr tablets
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Presentation.pptx
- 1. By : Radha Arrotex Pharmaceuticals
- 2. • Application :regulatory activity required in respect of a product: • Application category :ex:, category 1 and category 2 applications • Application Type: • New chemical/biological entity, new salt/ester/isomer/complex/derivative of an existing active ingredient, a similar biological medicinal product [A] • New fixed combination medicine [B} • Extension of indications [C] • Generic medicine [D] • Major variation (new dosage form, change/increase in patient group, change in dosage (eg., dosage amount, frequency of use or dose regimen), new strength, new route of administration) [F]
- 3. • Change in formulation [G] • Change in container type (disregarding container size) [G] • Other variation (requiring evaluation of clinical, nonclinical, or bioequivalence data) [H} • Variation to Register entry resulting in a change of product information requiring evaluation of clinical, nonclinical, or bioequivalence data [J]* • Extension of Provisional Registration [T] • Transition from provisional to full registration [S] • Dossier: • QUALITY,SAFETY,EFFICACY DATA
- 4. • 8 Phase , 8 milestones, Batch Processing Pre-Submission Phase -MS1 - Outcome of pre-submission planning sent Submission-MS 2- Outcome of application consideration sent First round assessment MS-3- Outcome of first round assessment and section 31 request for information or documents sent - Consolidated section 31 request response MS-4-End of section 31 request response period Second round assessment MS-5-Outcome of second round assessments sent Expert advisory review MS-6-Outcome of expert advisory committee review sent Decision MS-7-Decision made by delegate Post-decision MS-8-Administrative and regulatory activities complete.