scholarly journals A Mini Review on Challenges in Regulatory, Development and Clinical Development for Herbal Product

2020 ◽  
pp. 50-54
Author(s):  
Sruthi Bhat ◽  
Vishwanath Guddadar
Keyword(s):  
Clinical Trial ◽  
Herbal Product ◽  
Herbal Drugs ◽  
Regulatory Requirements ◽  
Herbal Products ◽  
Regulatory Status ◽  
Drug Clinical Trial ◽  
Regulatory Guidelines ◽  
Regulatory Development ◽  
Trade And Growth

A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. Different challenges and regulatory guidelines discussed for the clinical trial of herbal drugs will be useful for various industries for considering it before going ahead for clinical trial of their product. This mini review explore the various country herbal drug clinical trial procedures and potential.

scholarly journals A comparison of regulatory approval of clinical trial protocol with different countries

2021 ◽  
Vol 8 (3) ◽  
pp. 260
Author(s):  
K. Amaresh ◽  
Geetanjali Salimath ◽  
M. S. Ganachari ◽  
Revana S. Devarinti ◽  
Uday Kumar
Keyword(s):  
Clinical Trial ◽  
Drug Application ◽  
Regulatory Approval ◽  
Regulatory Body ◽  
Trial Protocol ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Clinical Trial Protocol ◽  
Clinical Trial Application ◽  
Regulatory Guidelines

<p class="abstract">In present scenario, different countries must follow different regulatory requirements for protocol approval process of new drug application. Present study, we studied the regulatory requirements, timelines of approval and guidelines according to central drug standard control organization (CDSCO), therapeutic goods administration (TGA), food and drug administration (FDA) and European medical agency (EMA). The objective was to compare the regulatory approval of clinical trial protocol process. A comparative observational study was undertaken among the clinical trials and regulatory bodies of India (CDSCO), Australia (TGA), US (USFDA), Europe (EMA). The study specified various regulatory guidelines and safety requirements for conduct and inspection of clinical trial. Clinical trial protocol guidelines the essential documents are determined, and various timelines are being identified. And compared with the fees with other countries. Indian payments were compared with other countries. Timelines with safety reporting were compared with other 3 countries (Europe, Australia and US). The regulatory guidelines in the clinical trial different between countries. There is different timelines and requirements of clinical trial application approval process for each regulatory body. This study methodology has enabled comparisons to be made both within agencies and between different authorities and has identified differences in the timelines that applications spend in different stages of the review.</p><p> </p>

Herbal Medicine: Clinical Perspective & Regulatory Status

2020 ◽  
Vol 23 ◽  
Author(s):  
Md Abul Barkat ◽  
Anjali Goyal ◽  
Harshita Abul Barkat ◽  
Mohammad Salauddin ◽  
Faheem Hyder Pottoo ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Herbal Medicines ◽  
New Drugs ◽  
Herbal Drugs ◽  
Clinical Perspective ◽  
Regulatory Status ◽  
Novel Drugs ◽  
History Of ◽  
Pros And Cons ◽  
Health Complications

Abstract:: Herbal medicines pays an important in treating the vaious diseases mainly due to the their potentially high therapeutic values and also due to the better acceptance of vaioruspatient under different health complications. The herbal medicine practice involves use of part of plant, entire plant or the selectctive isolated phytomedicineand the use and practices based on these has its pros and cons and has been greatly affected during the dawn. The search of new drugs during scientific era revives the interest in discovery of herbal drugs from different natural resources during 20th century. The present modern healthcare system invovlves utilization drugs and 50% of them are of ofnaural origin. Herbal drug disocovery found to be highly costly affair with low success rate and it hinders the further progress in utilizting the phytomedicine in treating the various deseases. But in recent years there is an increase in the search interest of herbal drugs mainly by the pharmaceutical industry and those invoves in the search of novel drugs from the herbs. Discovery of such new novel phytomedicines has to overcomes various challenges in indentification of active extracts and their toxicity, advereffects, herb drug interaction and importantly their regulatory requirments. The present review mainly focused on the history of herbal medicine, current clinical perspective, pharmaceutical, and regulatory challenges as well as its clinical presentation. Moreover, problems encountered in drug discovery from herbal resources and its possible solutions are delineated.

A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

2020 ◽  
Vol 7 (3) ◽  
pp. 162-176
Author(s):  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
Vikas Rathee
Keyword(s):  
Regulatory Requirements ◽  
Health Value ◽  
Drug Products ◽  
Registration Process ◽  
Potential Market ◽  
Regulatory Guidelines ◽  
Cis Countries ◽  
In Cis ◽  
Regulatory Organization ◽  
Country Specific

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

Artemeter-Lumefantrine therapeutic efficacy, safety and plasma levels in patients with uncomplicated falciparum malaria from the Colombian Pacific región

Infectio ◽  
2018 ◽  
Vol 22 (4) ◽  
pp. 199
Author(s):  
Alberto Tobón-Castaño ◽  
Luisa Garcés-Murillo ◽  
Alexandra Ríos-Orrego ◽  
Jehidys Montiel-Ramos ◽  
Briegel De Las Salas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Falciparum Malaria ◽  
Therapeutic Efficacy ◽  
Plasma Concentrations ◽  
Plasmodium Falciparum Malaria ◽  
Therapeutic Failure ◽  
World Health ◽  
Blood Levels ◽  
Drug Clinical Trial ◽  
Parasitological Response

Introduction: In Colombia, the published studies for the treatment of uncomplicated Plasmodium falciparum malaria with Artemether-Lumefantrine are scarce. The aim of the study was to evaluate the therapeutic efficacy and safety profile of this combination.Methods: A clinical trial was performed in adults with uncomplicated P. falciparum malaria using the 28-day World Health Organization validated protocol. Patients received supervised antimalarial treatment and the primary efficacy endpoint was the clinical and parasitological response. Safety was assessed through adverse events surveillance and plasmatic levels of antimalarial drugs were measured.Results: 88 patients were included. Adequate clinical and parasitological response rate of 100% on day 28 was achieved in 84 patients, diagnosed by thick blood smear examination. There were four parasitological therapeutic failures (5%) detected by polymerase chain reaction.Discusion: Therapeutic efficacy similar to previous studies was established with a slight increase in therapeutic failure. The serum levels of the antimalarials were adequate and the few cases of therapeutic failure were not related.Conclusion: Treatment of uncomplicated P. falciparum malaria with Artemeter-Lumefantrine was effective and safe in the study population. All patients reached adequate plasma concentrations of the drugs; therapeutic failures were not associated with low blood levels of the drug clinical trial.

scholarly journals AN EXHAUSTIVE REVIEW ON HERBS USED IN THE MANAGEMENT OF DIABETES MELLITUS TYPE 2

2019 ◽  
pp. 5-11
Author(s):  
Salman Mau ◽  
Shakir Saleem ◽  
Vishwadeepak Kimothi ◽  
Vineet Joshi ◽  
Sanjay Singh
Keyword(s):  
Diabetes Mellitus ◽  
Raw Materials ◽  
Nigella Sativa ◽  
Low Cost ◽  
Herbal Medicines ◽  
Analytical Techniques ◽  
Herbal Drugs ◽  
Herbal Products ◽  
High Blood Glucose ◽  
Glucose Levels

Diabetes mellitus is one of the most common metabolic disorders associated with disturbed hormonal secretion. Diabetes is characterized by high blood glucose levels over a prolonged period of time. High sugar levels are due to abnormal metabolism of carbohydrates and lipids which is caused by absolute or relative insulin deficiency. Herbal medicines have been the highly esteemed source of medicine throughout the human history. Herbs are becoming more popular today because of their least side effects, holistic beliefs, easy availability and low cost. Individual herbal products and formulations are gaining popularity because of their quality manufacturing using modern analytical techniques and standardized raw materials. Herbal drugs are widely used for the treatment of diabetes worldwide in various dosage forms. India has a long list of native herbal drugs with scientifically proven blood sugar lowering properties. The seeds of Nigella sativa, Olea europaea, fruits of Aegle marmelos, Momordica charantia, Coccinia indica, Nigella sativa,Gymnema sylvestre leaves,whole plant of Pterocarpus marsupium, Syzygium cumini fruits, Swertia punicea, Urtica dioica, gum of Ferula assa-foetida and seeds of Trigonella foenum graecum were discussed along with their reported mechanisms of action. In this review paper an attempt has been made to give an overview of certain Indian plants which have shown their anti-diabetic activity in various pre-clinical studies.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

Sign in / Sign up

Export Citation Format

Share Document