Regulatory and Quality Compliance of Oncology Products – A Global perspective
Abstract
The development and manufacturing of oncology products pose unique challenges in ensuring both regulatory compliance and high-quality standards. Oncology products, often complex biopharmaceuticals, play a critical role in cancer treatment, necessitating stringent oversight to safeguard patient safety and therapeutic efficacy. This abstract provides an overview of the key considerations in regulatory and quality compliance within the context of oncology product development.
Regulatory agencies worldwide, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others, have established comprehensive guidelines specific to oncology product development. These guidelines address various stages, from preclinical studies to clinical trials and market approval. Robust regulatory strategies, including well-designed clinical trial protocols and effective interactions with regulatory authorities, are essential to navigate the complex regulatory landscape.
The manufacturing of oncology products demands adherence to strict quality standards to ensure product consistency, safety, and efficacy. Good Manufacturing Practice (GMP) regulations set forth by regulatory agencies require manufacturers to implement and maintain quality systems throughout the entire production process. Quality control measures, including rigorous analytical testing, process validation, and aseptic processing, are crucial components in achieving and maintaining compliance. Oncology products often have unique safety profiles, and risk management plays a pivotal role in regulatory and quality compliance. Comprehensive risk assessments, including identification and mitigation strategies for potential risks, are integral components of regulatory submissions. Post-marketing surveillance and pharmacovigilance programs contribute to ongoing risk assessment and management.
Ensuring regulatory and quality compliance in the development and manufacturing of oncology products is essential for bringing safe and effective therapies to patients. A thorough understanding of regulatory guidelines, implementation of robust quality systems, and proactive risk management strategies are critical elements in navigating the dynamic landscape of oncology product development.
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References
https://www.who.int/publications/m/item/trs986-annex2
2. Patel KT, Chotai NP. Documentation and records: Harmonized GMP requirements. J Young Pharm [Internet]. 2011 [cited 2024 Mar 11];3(2):138–50. Available from: http://dx.doi.org/10.4103/0975-1483.80303
3. Center for Drug Evaluation, Research. Current Good Manufacturing Practice—guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act guidance for industry [Internet]. U.S.FDA; 2021 [cited 2024 Mar 13]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-guidance-human-drug-compounding-outsourcing-facilities-under
4. ICH Q7 Good manufacturing practice for active pharmaceutical ingredients - Scientific guideline [Internet]. Europa.eu; 2000 Nov 01. [cited 2024 Mar 12]. Available from:
https://www.ema.europa.eu/en/ich-q7-good-manufacturing-practice-active-pharmaceutical-ingredients-scientific-guideline
5. EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines [Internet]. Public Health, European Commission; 2011 Feb 07 [cited 2024 Mar 11]. Available from:
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
6. Center for Drug Evaluation, Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations [Internet]. US FDA; 2014 Mar [cited 2024 Mar 11]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioavailability-and-bioequivalence-studies-submitted-ndas-or-inds-general-considerations
7. Center for Drug Evaluation & Research. Bioavailability Studies Submitted in NDAs or INDs – general considerations [Internet]. US FDA; 2022 Apr [cited 2024 Mar 11]. Available from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioavailability-studies-submitted-ndas-or-inds-general-considerations
8. Investigation of bioequivalence - Scientific guideline [Internet]. Europa.eu; 2010 Mar 10 [cited 2024 Mar 11]. Available from:
https://www.ema.europa.eu/en/investigation-bioequivalence-scientific-guideline
9. U. Nitin Kashyap et. al. Comparison of Drug Approval Process in United States & Europe J. Pharm. Sci. & Res. 2013 Jun; 5(6):131 – 136.
10. Center for Drug Evaluation, Research. The Biopharmaceutics Classification System (BCS) guidance [Internet]. U.S FDA; 2017 Dec 22 [cited 2024 Mar 12]. Available from:
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/biopharmaceutics-classification-system-bcs-guidance
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