International journal of drug regulatory affairs最新文献

{"title":"Similarities and differences in filing for Drug Master File in US, Canada and Europe","authors":"Unnati Suthar, Zuki Patel, Vinit Movaliya, Niranajan Kanaki, Shrikalp Deshpande, Maitreyi Zaveri","doi":"10.22270/ijdra.v11i3.613","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.613","url":null,"abstract":"Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the applicable authority in the intended drug market. The document provides the non-supervisory authority with confidential, detailed information about installations, processes, or papers used in the manufacturing, processing, packaging, and storing of one or further mortal drugs. The DMF form allows an establishment to cover its intellectual property from its mate while complying with non-supervisory conditions for exposure of processing details. There is no non-supervisory demand to file a DMF. Drug Master Files (DMF) is a document containing complete information on an Active Pharmaceutical element (API) or finished drug capsule form. Though there are no non-supervisory conditions to file a DMF, the benefit of its use is inviting. A drug Master Files (DMF) is an voluntary non-supervisory submission and is submitted at the discretion of the DMF holder to help their guests. A DMF is NOT a cover for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. An Active Substance Master File (ASMF) is the presently honored term in Europe, formerly known as European drug Master file (eDMF) or a US- Drug Master File( US- DMF) in the United States.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"44 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135108505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Building Bridges: Harmonization efforts for enhanced collaboration between developed and developing countries","authors":"Neha Raut, Komal Bajaj, Prathmesh Matte, Muskan Vhora, Vinita Kale, Milind Umekar, Suankit Harane","doi":"10.22270/ijdra.v11i3.622","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.622","url":null,"abstract":"The harmonization efforts among regulatory bodies and stakeholders from developed and developing countries in the global healthcare landscape specifically focus on initiatives taken by CDSCO in India, MHLW in Japan, the TGA in Australia, ASEAN countries, and the US. The objective is to examine the importance of building bridges between these regions and harmonizing regulatory frameworks in the pharmaceutical and healthcare industries. The challenges faced include disparities in resources, technological capabilities, cultural differences, and regulatory frameworks. However, collaboration offers benefits such as increased access to affordable medicines, knowledge sharing, regulatory convergence, and capacity-building programs. International organizations like ICH play a role in facilitating harmonization efforts. Aligning regulatory systems and collaboration can enhance patient safety, facilitate trade, attract investment, and foster innovation. This paper concludes that harmonization efforts among CDSCO, MHLW, TGA, ASEAN countries, and the US can create a more integrated and equitable global healthcare ecosystem, bridging the gap between developed and developing countries.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135108506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A comparative evaluation of Regulatory requirements for Registration of Dietary Supplements in Brazil, Russia, India, China and South Africa","authors":"Kinjal Gajjar, Zuki Patel, Vinit Movaliya, Niranajan Kanaki, Shrikalp Deshpande, Maitreyi Zaveri","doi":"10.22270/ijdra.v11i3.616","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.616","url":null,"abstract":"Nutraceuticals are products that are rich in nutrients and provide health benefits, because of many factors like lifestyle changes and change in the dietary habits of people now a day, these products are widely used. Among all the other categories of Nutraceuticals Dietary supplement comprises huge part of Nutraceuticals. They are distinguishable from conventional food or drugs. They are intended to use to supplement the normal diet. The terms, nomenclature and definitions of the dietary supplements vary throughout the world. Different countries have their own regulation and legislative requirements. In regulated countries streamlined regulations are there, while well-structured and streamlined regulations for Nutraceuticals are lacking in other countries. In developing and emerging nations the regulation of dietary supplements are constantly evolving. It is necessary that the product complies all the regulatory requirements before they are placed on the market. The proposed study is based on the regulation and legislative requirements of dietary supplements in Brazil, Russia, India and South Africa.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135108504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug Product and Drug Substance (CADIFA) Registration process in Brazil","authors":"Pankaj Nerkar, Atul P. Patil, Mayuri V. Ahire, Suhas R. Mahajan, Swati D. Raysing","doi":"10.22270/ijdra.v11i3.607","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.607","url":null,"abstract":"There is a significant demand for improved healthcare and advanced pharmaceuticals in Brazil, presenting lucrative opportunities for foreign investors. However, engaging in business activities in Brazil can be challenging due to various factors. The process of registering pharmaceutical products in the country is time-consuming. Moreover, the highly regulated, complex, and fragmented Brazilian healthcare system, which is prone to corruption, can pose significant difficulties for small and medium-sized enterprises lacking the necessary financial resources and market knowledge. To comply with regulations, companies must provide detailed information about their drug products, including specifications, leaflets/labels, precautions, and other crucial details, all of which must be submitted in Portuguese in a comprehensive dossier. It typically takes close to a year to complete the medical registration process. In Latin America, specifically Brazil, Argentina, and Chile, there is a push to promote the registration of generic products by reducing the associated costs. Despite the obstacles and issues faced, Brazil's population of nearly 200 million people, its strategic position within Latin America, and its growing economy collectively present an appealing and promising market for various pharmaceutical sectors, offering potential for profitability.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135208837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nutraceutical Regulations in India: A comprehensive Review","authors":"Vaishnavi Ramdasi, Deepthi Lingala, Kaveri Macharam, Trapti Saxena, D. Prasanthi","doi":"10.22270/ijdra.v11i3.626","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.626","url":null,"abstract":"The term \"Nutraceutical\" was coined from \"nutrition\" and \"pharmaceutical\" in 1989, a Nutraceutical is any substance considered as a food or its part which, in addition to its normal nutritional value provides health benefits including the prevention of disease or promotion of health. Due to the adverse effects of drugs, consumers are preferring food supplements to improve health. Nutraceutical demand will grow with increasing risk of diseases is expected to boost product demand over the forecast period. High cost associated with healthcare treatments has resulted in rising consumer interest in Nutraceuticals. The Food Safety and Standards Authority of India (FSSAI) has been established, which consolidates various acts and orders that were in existence to handle food related issues in various Ministries and Departments. FSSAI has been created for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption. The regulatory framework of Nutraceuticals in India needs attention from the relevant authorities. Globally, the regulatory authorities are aware of changing needs of consumers and proactively protect consumers by amending existing laws to accommodate changes but in India old laws such as Prevention of Food adulteration Act, 1954, which regulates packaged foods, still exist for manufacturers.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135208836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug Shortage - Impact on the supply of critical drugs","authors":"Manan Shah","doi":"10.22270/ijdra.v11i3.614","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.614","url":null,"abstract":"In the United States (US), drug shortages have been a particularly prevalent issue, especially concerning generic drugs and biologics. These shortages affect treatments for a wide range of diseases, from mild to moderate conditions to severe life-threatening illnesses. The scarcity of oncology-related drugs is particularly concerning, as these medications play a crucial role in cancer treatment and have a direct impact on human lives. In this article, we will discuss two such drugs, Cisplatin and carboplatin, examining their causes of the current shortage and exploring potential solutions that could help alleviate these drug shortages.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135259916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the knowledge and practice of the Irish Community Pharmacists in reporting Adverse Drug Reactions and Falsified Medicines","authors":"Kanhai Hiren Kaj","doi":"10.22270/ijdra.v11i3.603","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.603","url":null,"abstract":"Background: Pharmacovigilance is a critical aspect of healthcare, enabling the monitoring of adverse drug reactions (ADRs), eradication of falsified medicines (FMs), identification of medication errors, monitoring off-license drug use, addressing abuse and misuse, assessing lack of efficacy, tracking poisoning incidents, managing drug-drug/food interactions, ensuring the destruction of expired stock, and evaluating drug-related mortality. It is essential for healthcare professionals to be aware of their role in Pharmacovigilance.
 Objective: This study aims to assess the current knowledge and reporting practices of ADRs and FMs among community pharmacists in Ireland, focusing on two important components of Pharmacovigilance.
 Method: The research employed a cross-sectional, observational design, utilizing an online questionnaire survey to gain insights into the pharmacists' knowledge and practices related to Pharmacovigilance programs, ADR reporting, FMs, and their opinions on their role in these areas.
 Results: The study found that Irish colleges and universities played a significant role in providing Pharmacovigilance education to pharmacy students. The majority of pharmacists demonstrated a good understanding of Pharmacovigilance, but only a third of them were aware of Irish legislation in this regard. Additionally, only 20.23% of pharmacists believed that Irish patients were aware of ADR reporting, although 92.49% were familiar with the Health Products Regulatory Authority's (HPRA) ADR reporting system. The findings suggest the need for pharmacists to educate their patients about ADR reporting, while recognizing the convenience of the HPRA reporting system.
 Conclusion: Overall, the study revealed that most community pharmacists possess a solid understanding of the fundamental aspects of Pharmacovigilance, including ADRs and FMs. However, there are areas for improvement, such as raising awareness among patients about ADR reporting. The findings highlight the importance of continuous education and communication to enhance Pharmacovigilance practices among community pharmacists in Ireland.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135259919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phytopharmaceuticals Regulatory requirements and licensing process","authors":"Pooja Prajapati, Asmatbanu Pathan, Denish Prajapati","doi":"10.22270/ijdra.v11i3.615","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.615","url":null,"abstract":"Since the ancient period, people have used herbal treatments for a wide variety of medical issues. In developing countries, most people utilize herbal remedies to cure a variety of diseases. India, the nation that produces the most medicinal plants, is referred to as the botanical garden of the world. Indian drug regulators are focused on quality in order to uphold the standards for herbal remedies, but manufacturers are struggling to satisfy the higher standards. There are difficulties with standardization, finished formulations, and industry-wide evidence-based practices for AYUSH medicines in India. Phytopharmaceuticals, a modern subclass of medications, contain an enriched fraction with at least four distinct chemical markers with one biomarker. The Central Drugs Standards Control Organization (CDSCO) oversees Phytopharmaceuticals. The Ministry of Health and Family Welfare has released a Gazette Notification GSR 918(E)-Schedule Y, Appendix I(B) regarding Phytopharmaceuticals. This new rule is anticipated to encourage new medication discoveries and evolution using botanicals in a scientific manner and would aid in the modern medical profession's acceptance of Phytopharmaceuticals as a significant alternative to allopathic modern medicine. Phytopharmaceuticals are a well-balanced approach that believes in everything but places emphasis on the revalidation of the plant material's specification, in contrast to conventional pharmaceuticals that suspect everything and AYUSH medicines that trust everything. The purpose of this article is to give specific detail and compiled knowledge about Phytopharmaceutical medicines, regulatory requirements, and regulatory processes.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135259918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative study of Regulatory requirement for preparation of Dossier for Registration of Veterinary Drug in US, EU and Canada","authors":"Swati Raysing, Pankaj Nerkar, None Siddhesh Sanghavi, Shewta Jogdand, Atul Patil","doi":"10.22270/ijdra.v11i3.619","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.619","url":null,"abstract":"The main purpose of this article is to research the requirement of the veterinary drug dossier submission in the three countries is US, EU, and Canada and the procedure of all the three countries are different for the submission of the veterinary drug dossier and their rules and regulation are different but all the three countries follow the VICH guidelines in these articles all the information available like necessary documents timeline approval procedure are different for US, EU, and Canada.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135259917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the Knowledge and Practices of Adverse Drug Reaction and Falsified Medicine Reporting Amongst the Community Pharmacists of India","authors":"Kanhai Hiren Kaj","doi":"10.22270/ijdra.v11i3.612","DOIUrl":"https://doi.org/10.22270/ijdra.v11i3.612","url":null,"abstract":"Background: Adverse drug reactions (ADRs) and falsified medicines (FMs) pose significant threat to patient safety and public health. Understanding the knowledge, experiences, and perspectives of community pharmacists in India regarding ADRs and FMs is crucial for effective intervention and prevention strategies.
 Objective: This study aimed to assess the knowledge, experiences, and perspectives of community pharmacists in India regarding ADRs and FMs. It sought to gather information on pharmacists' familiarity with the threats posed by ADRs and FMs, their understanding of relevant legislation, their personal encounters with ADRs and FMs, and their views on the distribution of FMs and the adequacy of existing legislation.
 Method: A survey was conducted among community pharmacists in India, and data were collected using a questionnaire. The survey included questions related to knowledge, experiences, and perspectives on ADRs and FMs. The responses were analysed to identify trends and key findings.
 Results: The analysis revealed that a significant majority of pharmacists demonstrated a fundamental understanding of ADRs and FMs. However, a relatively low percentage reported encountering ADRs as well as FMs in their practice, with an equally low proportion reporting these incidents to the appropriate authorities Majority of pharmacists believed that they plan an important role in reporting of ADRs but only half of the pharmacists’ surveyed things that they plan an important role in tackling the issue of FMs.
 Conclusion: The research highlights that community pharmacists in India have a good understanding of Pharmacovigilance and ADR reporting, although knowledge of Indian legislation needs improvement. Pharmacists demonstrate a positive attitude towards ADR reporting and promptly report encountered ADRs and FMs. Patient education, convenience of the reporting system, and strengthening FM legislation are areas that require attention. Major sources of FM distribution are online pharmacies and street hawkers. These findings contribute to enhancing pharmacovigilance practices and addressing FM distribution in India.","PeriodicalId":475095,"journal":{"name":"International journal of drug regulatory affairs","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135485780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}