Cargando…

Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities

BACKGROUND: The regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities. The variation is particularly wide between High-income countries (HIC) and lower and middle-income countries (LMIC) with different regulatory framewo...

Descripción completa

Detalles Bibliográficos
Autores principales:	Thambavita, D., Galappatthy, P., Jayakody, R. L.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2018
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6011264/ https://www.ncbi.nlm.nih.gov/pubmed/29951208 http://dx.doi.org/10.1186/s40545-018-0141-2

Ejemplares similares

WHO/INRUD Core drug use indicators and commonly prescribed medicines: a National Survey from Sri Lanka
por: Galappatthy, P., et al.
Publicado: (2021)

A national survey on registered products, availability, prices, and affordability of 100 essential medicines in community pharmacies across Sri Lanka
por: Liyanage, Chiranthi Kongala, et al.
Publicado: (2023)

Regulatory requirements and labeling of commercially available prescription (oral) medicines in Sri Lanka: there is room for improvement
por: Jayasinghe, Manori, et al.
Publicado: (2022)

Safety monitoring of treatment in bipolar disorder in a tertiary care setting in Sri Lanka and recommendations for improved monitoring in resource limited settings
por: Mannapperuma, Uthpali, et al.
Publicado: (2019)

IVF in Sri Lanka: A concise history of regulatory impasse
por: Simpson, Bob
Publicado: (2016)

Requirements for generic anti-epileptic medicines: a regulatory perspective
por: Maliepaard, Marc, et al.
Publicado: (2009)

Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes()
por: Dellepiane, Nora, et al.
Publicado: (2018)

Attention for sex in COVID-19 trials: a review of regulatory dossiers
por: de Vries, Sieta T, et al.
Publicado: (2022)

Sex Difference in Risk Factors, GRACE Scores, and Management among Post-Acute Coronary Syndrome Patients in Sri Lanka
por: Galappatthy, Priyadarshani, et al.
Publicado: (2020)

Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022
por: Moeti, Lerato, et al.
Publicado: (2023)

A history of medicine in Sri Lanka
por: Librach, I. M.
Publicado: (1987)

Genetics and genomic medicine in Sri Lanka
por: Sirisena, Nirmala D., et al.
Publicado: (2019)

Determinants of under-five mortality in Sri Lanka: A multilevel analysis of 2016 Sri Lankan DHS data
por: Thabrew, Kaludura Anupama Seuwandi, et al.
Publicado: (2023)

A Retrospective Analysis of Applications for Registration of Generic Medicines Processed by the Medicines Control Authority of Zimbabwe
por: Samunda, Brilliant Tinashe, et al.
Publicado: (2022)

Medicine prices, availability and affordability in Sri Lanka
por: Senarathna, S.M.D.K. Ganga, et al.
Publicado: (2011)

Medicinally Important Herbal Flowers in Sri Lanka
por: Gunawardana, S. L. A., et al.
Publicado: (2019)

Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities
por: McAuslane, Neil, et al.
Publicado: (2023)

Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)
por: Moeti, Lerato, et al.
Publicado: (2022)

Manufacturer Response to AMCP Format Dossier Requests
por: Lyles, Alan, et al.
Publicado: (2007)

Melioidosis in Sri Lanka
por: Corea, Enoka M., et al.
Publicado: (2018)

Opportunities and challenges for verbal autopsy in the national Death Registration System in Sri Lanka: past and future
por: Dharmaratne, Samath D, et al.
Publicado: (2011)

Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019
por: ter Horst, Judith P., et al.
Publicado: (2021)

Dosfilos, dossier /
Publicado: (1989)

Bibliothèques: dossier
por: Van Dooren, Bruno
Publicado: (1993)

An annotated species list of regular echinoids from Sri Lanka with notes on some rarely seen temnopleurids
por: Arachchige, Gayashan M., et al.
Publicado: (2019)

Prevalence of Hypertension and Its Associated Factors among a Group of Bus Drivers in Colombo, Sri Lanka
por: Jayarajah, Umesh, et al.
Publicado: (2016)

Establishing a core dossier for multiple regulatory submissions: a case study in the Latin America region
por: Alvarez, Alva Lucia, et al.
Publicado: (2023)

Historical Evolution and Present Status of Family Medicine in Sri Lanka
por: Ramanayake, R. P. J. C.
Publicado: (2013)

Implementation of genomic medicine in Sri Lanka: Initial experience and challenges
por: Sirisena, Nirmala D., et al.
Publicado: (2016)

History of opium in Sri Lanka.
por: Uragoda, C G
Publicado: (1983)

Cutaneous Leishmaniasis, Sri Lanka
por: Nawaratna, Sujeevi S.K., et al.
Publicado: (2007)

Sri Lanka Malaria Maps
por: Briët, Olivier JT, et al.
Publicado: (2003)

Swine Influenza in Sri Lanka
por: Perera, Harsha K. K., et al.
Publicado: (2013)

Pesticide exposure in Sri Lanka
por: Knipe, DW
Publicado: (2016)

Liver Disease in Sri Lanka
por: Wijewantha, Hasitha S
Publicado: (2017)

Cervical Cancer in Sri Lanka
por: Iqbal, Ahamed, et al.
Publicado: (2023)

Impact of regulatory requirements on medicine registration in African countries – perceptions and experiences of pharmaceutical companies in South Africa
por: Narsai, Kirti, et al.
Publicado: (2012)

A comprehensive study on regulatory requirements for development and filing of generic drugs globally
por: Handoo, Shweta, et al.
Publicado: (2012)

Dossier Wallon-Piaget
por: Clanet, Claude
Publicado: (1984)

Species composition and population dynamics of malaria vectors in three previously ignored aquatic systems in Sri Lanka
por: Fernando, Achini W., et al.
Publicado: (2016)

Cannot write session to /tmp/vufind_sessions/sess_5ifuhi292eg3l53vdduco13458