Study on generic drug registration in ASEAN emerging markets.
Journal name: World Journal of Pharmaceutical Research
Original article title: Comprehensive study on the registration of generic drug product in the emerging market (asean)
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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Kundara Prerna and Garg Minakshi
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Comprehensive study on the registration of generic drug product in the emerging market (asean)
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
The registration of generic drug products within the Association of Southeast Asian Nations (ASEAN) presents a complex landscape due to varying regulatory requirements across member states. The ASEAN market has garnered interest from pharmaceutical companies owing to its economic growth and improving infrastructure. However, navigating the country-specific regulations can pose significant challenges for these firms. This comprehensive study highlights the complexities involved in the registration process while aiming to provide an in-depth summary of regulatory requirements in the ASEAN region.
Harmonization Efforts in ASEAN
One of the major initiatives aimed at improving the pharmaceutical regulatory landscape in the ASEAN region is the establishment of the ASEAN Consultative Committee on Standards and Quality Pharmaceutical Product Working Group (ACCSQ PPWG). This body was formed in 1999 and is focused on harmonizing pharmaceutical guidelines across member states to eliminate technical barriers to trade while maintaining drug quality, safety, and efficacy. The ACCSQ PPWG has worked to develop the ASEAN Common Technical Document (ACTD), which serves as a structured format for submitting drug registration applications, aligning them more closely with international standards like the ICH Common Technical Document (ICH-CTD).
The ASEAN Common Technical Document (ACTD)
The ACTD is a crucial component of drug registration in ASEAN, providing a guideline that standardizes the dossier format for regulatory submissions. Comprising four parts—administrative data, quality information, non-clinical information, and clinical information—the ACTD facilitates the registration process by streamlining documentation requirements. Although generally aligned with the ICH-CTD, the ACTD is less stringent in its detailed documentation requirements. This flexibility allows for easier navigation through the registration processes in different ASEAN countries, which often accept reference applications from other regions as part of their evaluation criteria.
Country-Specific Registration Requirements
Despite the establishment of the ACTD, individual ASEAN member states maintain their own specific registration processes and requirements. For example, Malaysia's National Pharmaceutical Regulatory Division requires a comprehensive set of documents categorized under either scheduled or non-scheduled poison classifications. Similarly, Singapore mandates that generic drug products demonstrate bioequivalence to a reference product. Brunei, Myanmar, Vietnam, and other nations in the region have their specific documentation and submission guidelines, further complicating the registration process. The variation in requirements makes it challenging for pharmaceutical companies aiming for simultaneous registration across multiple countries.
Conclusion
In conclusion, the registration of generic drug products in the ASEAN region is characterized by a challenging regulatory landscape marked by both harmonization efforts and individual member state requirements. The ACCSQ PPWG's initiatives, such as the creation of the ACTD, represent significant steps towards standardization. However, the ongoing disparities in regulatory practices still pose considerable challenges for pharmaceutical firms seeking to enter these emerging markets. Addressing these hurdles through enhanced collaboration and further harmonization of regulations among ASEAN countries would be beneficial in facilitating faster access to essential medications for the population, thereby improving public health outcomes in the region.
FAQ section (important questions/answers):
What is the aim of the comprehensive study on drug registration?
The study aims to provide a detailed summary of the regulatory requirements for registering generic drug products in ASEAN member countries, highlighting challenges and variations in the registration processes.
What is the ACTD format used for in ASEAN countries?
The ASEAN Common Technical Document (ACTD) format is a standardized submission format for regulating pharmaceutical applications across ASEAN member states, aimed at simplifying and streamlining the drug registration process.
How does drug registration differ across ASEAN member states?
Each ASEAN member state has its own specific requirements and procedures for drug registration, influenced by country-specific laws and regulations, despite sharing some common frameworks.
What key documents are required for drug registration in Malaysia?
Malaysia requires a completed application form, administrative data, product information, quality documentation, GMP certificates, and other specifics based on whether the drug is scheduled or non-scheduled poison.
What challenges do pharmaceutical companies face in ASEAN drug registration?
Pharmaceutical companies encounter challenges such as varying regulatory requirements, documentation demands, and the need for compliance with country-specific guidelines, complicating simultaneous registrations across multiple countries.
Why is the ASEAN market attractive for pharmaceutical companies?
The ASEAN market is appealing due to its growing population, improving trade and communication infrastructures, and expanding pharmaceutical market opportunities, making it a lucrative area for investment and product registration.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Study on generic drug registration in ASEAN emerging markets.”. 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:
Drugs, as the plural of drug, encompass a wide range of substances that can be used for medical or recreational purposes. In the context of the ASEAN regulations, drugs undergo rigorous testing and registration processes to ensure they are safe and effective for public use, demonstrating their importance in healthcare.
2) Substance:
Substances, the plural form, indicates the range of chemical entities that can be drugs, ingredients, or compounds used in the pharmaceutical and healthcare sectors. Regulatory agencies assess each substance's properties to determine its safety and effectiveness for therapeutic use.
3) Quality:
Quality in the pharmaceutical context encompasses the characteristics of a drug or substance that include safety, efficacy, and consistency. Regulatory frameworks focus on ensuring the quality of medicines through strict guidelines, certifications, and monitoring processes, essential for protecting public health and ensuring therapeutic effectiveness.
4) Medicine:
Medicines, as the plural of medicine, encompass various therapeutic agents used to treat health conditions. Regulatory bodies provide oversight to ensure these products meet established safety and quality standards, fostering public confidence in healthcare systems and access to effective disease management tools.
5) Food:
Food, while primarily referring to substances consumed for nutritional purposes, intersects with the pharmaceutical industry regarding safety standards for combination products or dietary supplements. Regulatory frameworks ensure that food products, especially those claiming health benefits, comply with stringent safety and labeling guidelines.
6) Company:
Company indicates a legal entity engaged in business activities, including pharmaceutical firms involved in drug development, production, and marketing. Regulatory compliance is critical for companies in the pharmaceutical sector, as they must adhere to specific regulations to ensure the safety and efficacy of their products.
7) Language:
Language plays a crucial role in the global pharmaceutical landscape, particularly in the context of documentation and regulatory submissions. Ensuring that technical data and product information are accurately conveyed in appropriate languages is essential for effective communication with regulatory authorities and consumers.
8) Container:
Container refers to the packaging used for holding pharmaceuticals and medications. The design and materials of containers are subject to regulatory scrutiny to ensure that they protect the drug's integrity, stability, and safety during storage and transport, which is vital for maintaining quality.
9) Table:
Table, in this context, typically refers to simplified representations of regulatory requirements or processes for drug approval. Tables can facilitate clearer understanding and navigation of complex regulations, offering stakeholders a quick overview of essential information vital for compliance and submissions.
10) Tai:
Thai pertains to Thailand or its culture, language, and regulatory practices in pharmaceuticals. As an ASEAN member, Thailand has specific regulations for drug registration, and its processes serve as a reference point for harmonization efforts across the region's regulatory frameworks.
11) Trade:
Trade refers to the exchange of goods and services, including pharmaceuticals, across different regions. Having a clear understanding of trade regulations is essential for pharmaceutical companies, as it affects market access, compliance requirements, and competitiveness in the ASEAN region.
12) Study (Studying):
Study refers to the systematic investigation or examination of pharmaceutical regulations and drug registration processes. Research in this area helps identify best practices and challenges within the regulatory landscape, informing stakeholders and guiding policy development in the pharmaceutical industry.
13) Science (Scientific):
Science refers to the systematic pursuit of knowledge through observation and experimentation. In the pharmaceutical context, scientific inquiry drives the development of new drugs and understanding of mechanisms of action, informing regulatory policies aimed at protecting public health.
14) Delhi:
Delhi serves as a focal point of pharmaceutical education and regulation in India, housing various institutions that contribute to drug regulatory affairs. The city's regulatory approaches influence practices in other regions, especially within the ASEAN framework, promoting harmonization.
15) Life:
Life represents the fundamental aspect of healthcare and pharmaceutical development, focusing on preserving and improving health outcomes. Understanding the implications of drug regulation is key to ensuring that life-enhancing medications are accessible, safe, and effective for the population.
16) Filling (Filled):
Filling specifically relates to the process of completing forms and applications necessary for regulatory compliance in the pharmaceutical industry. Ensuring accurate filling of forms is critical for the timely and successful registration of drug products.
17) New Delhi:
New Delhi, the capital of India, is a significant center for pharmaceutical policy-making and regulation. The convergence of regulatory authorities and educational institutions in New Delhi influences not only national policies but also provides a model for regulatory practices in the ASEAN region.
18) Merchandise:
Merchandise refers to goods or products that can be bought and sold, including pharmaceuticals. The regulation of pharmaceutical merchandise ensures that products meet standards for quality and safety, protecting consumers and stakeholders in the healthcare industry.
19) Animal:
Animals, in the context of biomedical research, serve as subjects for testing the safety and efficacy of pharmaceuticals. Regulatory frameworks establish ethical standards and guidelines ensuring humane treatment of animals in research.
20) India:
India plays a vital role in the global pharmaceutical industry, with a complex regulatory landscape that impacts drug development and availability. Its practices and policies can influence regulatory harmonization efforts throughout the ASEAN region, enhancing market accessibility.
21) Post:
Post often refers to activities or actions taken after a primary event, such as post-marketing surveillance in the drug lifecycle. Monitoring drug safety post-approval is vital for ensuring continued compliance with efficacy and safety standards.
22) Pharmacological:
Pharmacological refers to the study of how drugs interact with biological systems. Understanding pharmacological principles is essential for developing effective medications and demonstrates the need for rigorous testing and regulatory compliance in pharmaceutical research.
23) Developing:
Developing describes the ongoing process of creating and refining pharmaceutical products. In the context of regulatory affairs, it emphasizes the need for compliance with evolving guidelines and the importance of establishing quality standards in emerging markets.
24) Minakshi (Minaksi, Mina-akshi):
Minakshi likely refers to the co-author of the study and signifies the collaborative nature of research within the pharmaceutical field. Her contributions are central to understanding the regulatory environment and approaches to drug registration in ASEAN countries.
25) Mineral:
Mineral refers to a specific type of inorganic substance that can be implemented in drug formulations or supplements. Regulatory scrutiny of mineral products ensures they meet safety and efficacy standards, safeguarding consumer health.
26) Writing:
Writing encompasses the documentation process involved in preparing regulatory submissions or research articles. Accurate and clear writing is essential in the pharmaceutical sector to ensure that critical data is effectively communicated to regulatory authorities.
27) Meeting:
Meeting can refer to gatherings of regulatory bodies or stakeholders to discuss pharmaceutical regulations and practices. Collaborative meetings are important for harmonizing regulatory frameworks and addressing challenges in drug registration.
28) Account:
Account in the context of pharmaceuticals may refer to financial records or the documentation of regulatory compliance activities. Maintaining accurate accounts is essential for tracking adherence to guidelines and ensuring transparency in drug development.
29) Purity:
Purity refers to the absence of contaminants in drug substances, which is essential for ensuring safety and efficacy. Regulatory agencies enforce stringent quality control measures to maintain the purity of pharmaceuticals, critical for patient safety.
30) Reason:
Reason refers to the justification or motivation behind regulatory requirements or decisions made within the pharmaceutical industry. Understanding the reasons for regulatory actions helps stakeholders comply with established norms and facilitate drug approval processes.
31) Trader:
Trader pertains to individuals or companies involved in the commercial exchange of goods, including pharmaceuticals. Regulatory standards impact traders as they strive to ensure that the products offered meet safety, quality, and legal requirements.
32) Canopy:
Canopy typically refers to a protective cover but may be used metaphorically in the regulatory context to describe overarching policies or frameworks that safeguard public health. Such 'canopies' provide structure to the regulatory landscape in pharmaceuticals.
33) Field:
Field in the context of pharmaceuticals could denote a specific area of study or practice, such as pharmacology or drug regulation. Mastery of a field is essential for professionals aiming to contribute to the safe development and distribution of medicines.
34) Party:
Party generally refers to an entity involved in a legal agreement or regulatory process. In pharmaceutical regulation, parties can include regulatory authorities, manufacturers, and companies participating in compliance and approval processes.
35) Blood:
Blood can refer to biological samples used in pharmaceutical testing or development processes, especially in studying therapies and diagnostics. Regulations surrounding the use of blood samples ensure that they are handled ethically and safely in research.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Study on generic drug registration in ASEAN emerging markets.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Compliance, Pharmaceutical companies, Regulatory Framework, Patient information leaflet, Health authorities, Regulatory authority.