Review on drug approval process in kenya, tanzania, india, china
Journal name: World Journal of Pharmaceutical Research
Original article title: Review on drug approval process in kenya, tanzania, india, china
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Abhishek Mali, Sumit Joshi, Ganesh Dama and Sanket Gavhane
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Review on drug approval process in kenya, tanzania, india, china
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr202014-18891
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
The study described in this article offers a comprehensive comparison of the drug approval processes across various countries, particularly focusing on Kenya, Tanzania, India, and China. It underscores the significance of a stringent drug approval system to ensure the manufacturing of medicinal products that are both safe and effective. By examining regulatory frameworks in both regulated and non-regulated markets, the paper aims to enhance understanding of market dynamics and encourage the revision of regulations to foster public health.
Regulatory Frameworks in Drug Approval
One of the key points discussed is the structured regulatory framework set forth by different countries. For instance, Kenya's Pharmacy and Poisons Board oversees the drug approval process, which requires a series of meticulous steps, including the submission of multiple application forms, samples from production batches, and an assessment of clinical trials. The article highlights that the drug registration process in Kenya involves a turnaround time of approximately 90 working days for fast-tracked applications, which is a procedural assurance of the prioritization given to certain locally manufactured and essential medicines.
Differences in Regulatory Practices
Furthermore, the article compares regulatory practices between countries by categorizing them into regulated, semi-regulated, and non-regulated markets. Regulated markets, such as the US and EU nations, impose clear and stringent guidelines for drug approval, while semi-regulated markets, like India and various African countries, exhibit significant variation in the implementation and intensity of regulatory oversight. This disparity reveals crucial differences in the speed of approval, cost of applications, and compliance requirements, thus impacting the entry of generic and innovative drugs into these markets.
The Role of the Common Technical Document (CTD)
The use of the Common Technical Document (CTD) is emphasized as a vital component across the drug approval processes in the countries analyzed. This standardized format assists in the organization and submission of drug approval applications, ensuring a systematic approach that can streamline evaluations. By following CTD guidelines, applicants can facilitate a more efficient review process by regulatory bodies, thus increasing the likelihood of timely market authorization.
Conclusion
In conclusion, navigating the heterogeneous landscape of global drug approval processes presents challenges for pharmaceutical companies, especially those involved in generic drug development. As regulatory requirements continue to evolve across different regions, a strategic and well-coordinated approach to understanding these variances in regulatory frameworks is essential. Companies must carefully assess market needs and align their development strategies with the specific regulatory stipulations to optimize the potential for successful product launches while minimizing delays and costs associated with regulatory compliance.
FAQ section (important questions/answers):
What is the main objective of the drug approval process?
The main objective is to ensure that medicinal products meet acceptable quality and efficacy standards before being marketed.
What are the categories of the global market for drugs?
The global market is divided into regulated markets, semi-regulated markets, and non-regulated markets, each with varying levels of regulatory scrutiny.
What is required for drug registration in Kenya?
In Kenya, registration requires application forms, samples, certificates of analysis, and fees, among other documentation.
How does the drug approval process differ in India?
India's approval process involves the Central Drugs Standard Control Organization and varies in timeframes and requirements compared to other countries.
What agency regulates drugs in Tanzania?
The Tanzania Food and Drug Administration (TFDA) regulates drugs to ensure public health by ensuring quality and safety standards.
What challenges do pharmaceutical companies face in drug development?
Companies face challenges in meeting diverse regulatory requirements across countries, which necessitates careful planning and strategic coordination.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Review on drug approval process in kenya, tanzania, india, china”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
The plural form 'Drugs' encompasses multiple substances used for treatment or medication. This term highlights the vast array of pharmaceuticals available in the market, along with the need for strict regulatory processes to ensure their safety, efficacy, and quality across diverse international contexts.
2) India:
India is a significant player in the global pharmaceutical industry, especially renowned for its generic drug manufacturing. The regulatory landscape, defined by the Drugs & Cosmetics Act, emphasizes the importance of quality and compliance in drug approval, impacting both local and international markets.
3) Cina:
China represents one of the fastest-growing pharmaceutical markets worldwide. The country's drug approval process, managed by the State Food and Drug Administration, is critical for maintaining safety and efficacy standards, showcasing the importance of regulatory frameworks in supporting public health while facilitating market access.
4) Quality:
Quality in pharmaceuticals refers to the standard of safety, efficacy, and manufacturing processes upheld by regulations. Ensuring high quality is vital not only for patient safety but also for maintaining trust in drug products, which is critical for their acceptance in regulated markets.
5) Food:
The inclusion of 'Food' relates to the broader regulatory sphere governing consumables, such as pharmaceuticals and dietary supplements. Understanding the intersection between food safety regulations and drug approvals helps ensure comprehensive public health protection across various product categories.
6) Table:
In this context, 'Table' likely refers to organized presentations of information, summarizing regulatory requirements and processes. Tables facilitate comparison and understanding of complex data related to drug approvals, making it easier for stakeholders to grasp essential regulatory guidelines.
7) Medicine:
The plural 'Medicines' encompasses a range of therapeutic products. A clear understanding of the regulatory landscape surrounding medicines is crucial for ensuring they meet safety and quality expectations in different markets, ultimately affecting public health and access to healthcare.
8) Study (Studying):
'Study' represents a systematic examination of drug approval processes and regulatory requirements across various countries. This study aids pharmaceutical stakeholders in navigating complex regulations, ensuring compliance, and ultimately facilitating market access for new and existing drug products.
9) Maharashtra (Maharastra, Maha-rashtra):
Maharashtra is a state in India that hosts many pharmaceutical companies and educational institutions. The region's regulatory framework and its emphasis on quality assurance contribute significantly to the pharmaceutical industry's development, impacting the dissemination of knowledge and regulatory compliance in drug manufacturing.
10) Language:
The term 'Language' highlights the significance of communication in regulatory affairs. Effective language use is essential for preparing documentation, understanding guidelines, and facilitating discussions among regulatory authorities, ensuring critical information is accessible across varying linguistic contexts.
11) Filling (Filled):
The term 'Filled' pertains to the necessary completion of forms or applications within the drug approval process. Accurate and thorough filling of regulatory documents is vital for ensuring compliance and expediting the review process, influencing time to market for pharmaceutical products.
12) Pune:
Pune, a notable city in Maharashtra, India, is recognized for its educational institutions and pharmaceutical firms. The region contributes to advancements in pharmaceutical research and regulatory affairs, fostering an environment that supports the development of quality medicines and adherence to regulatory standards.
13) Collecting:
'Collecting' suggests the gathering of data or fees associated with drug regulation. Proper management of fees ensures the sustainability of regulatory authorities, allowing them to maintain oversight of drug approval processes and uphold public health standards.
14) Panama:
Panama represents a significant location in the discussion about drug regulation in Latin America. Understanding the regulatory frameworks in nations like Panama is essential for pharmaceutical companies seeking to penetrate diverse markets and facilitate access to medicines globally.
15) Lanka (Lamka, Lànkà):
Lanka, referring to Sri Lanka, is important for contextualizing drug regulation in the South Asian region. Regulatory frameworks in Sri Lanka interact with those of neighboring countries, highlighting the need for understanding regional compliance and harmonization efforts in drug approvals.
16) Joshi (Josi):
Joshi indicates a co-author involved in the study, emphasizing collaborative research in understanding drug regulations. Individual contributions from professionals like Joshi enrich the analysis of regulatory processes, facilitating insights necessary for effective pharmaceutical development and compliance.
17) Ghana:
Ghana represents an essential aspect of the regulatory landscape in Africa. Understanding its local drug approval processes and requirements is crucial for pharmaceutical companies aiming to operate effectively in growing markets within the continent, ensuring compliance with regional health standards.
18) Rules:
The term 'Rules' refers to the established guidelines and regulations governing drug approval processes. Adhering to these rules is essential for pharmaceutical companies to ensure compliance, ultimately affecting product quality and safety in the marketplace.
19) Dama:
Dama signifies a co-author contributing to the study, representing teamwork in the research and understanding of drug regulations. Contributions from such professionals are vital for providing comprehensive insights and recommendations for the pharmaceutical industry's regulatory challenges.
20) Post:
'Post' relates to activities conducted after drug approval, such as post-marketing studies, which are integral for monitoring ongoing drug safety and efficacy. This stage ensures that any emerging concerns are addressed, enhancing the overall regulatory framework aimed at protecting public health.
Other Science Concepts:
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