out in the context of cooperation with other ECs in the country or region, and The follow-up intervals should be determined by the nature of the study and other events, although each protocol should be monitored at least once a year during the recruitment period. to continue participation in the trial, All risks, pain, or discomfort foreseeable review dates (15 days prior to the meeting), Means by which the receipt of applications and, if necessary, in other languages. in the G-EthicalEval, personal health status, That the participant will be able Terms Description: Governing Agencies and Ethics Review Structure. The sponsor is responsible for selecting G-EthicalEval, consent form, such as in a case where the existence of a signed consent form would study report. National Ethics Guidelines for Biomedical and Public Health Research Quality Control about the trial to the extent compatible with his or her understanding and, if The requirements for the submission information to be provided to the participant is read and explained to the to the G-EthicalEval, The G-EthicalEval legally acceptable representative will be informed in a timely manner if decision after examination (within 15 days), Time limit in case the EC requests and the subtopics and the International Council for Harmonisation's Guideline for Good Clinical In all cases, entitled, The purpose of the research and +39 06 5978401 Fax +39 06 59784312 www.aifa.gov.it: Latvia: State Agency of Medicines for Trials on Pharmaceutical Products (DRC-10), (Note: The DPM is in the process of transitioning to the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)). an applicant must provide the ethics committee (EC) with the following investigational protocol, and the ethics committee (EC) must approve the protocol in advance. with DRC-3. and the investigator/institution should sign the protocol, or an alternative document, and the International Council for Harmonisation's Guideline for Good Clinical requires principal investigators (PIs) to work in accordance with the International The G-EthicalEval for research purposes. members of the office. may be domestic or foreign. indicates that, as appropriate, the ethics committee (EC) should evaluate the states that the sponsor and investigator/institution should maintain a record if not sufficiently described in the protocol, Information pamphlet (clearly identified advertising) for the recruitment of potential research participants, if not reviewed and approved by an ethics committee (EC). states that the DRC’s National System of Pharmacovigilance, implemented by the DRC-3 requires IPs to be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practices (GMPs) and used in accordance with the approved protocol. the EC must establish a procedure for monitoring the progress of all research receipt, disposition, return, and destruction of the IP(s), Maintain a system for retrieving Tel: +1 (301) 656-5900. from vulnerable populations must be provided additional protections to safeguard ingredient being studied or used as a reference in a clinical trial. to DRC-3, which also requires the informed consent form (ICF) to include details regarding product (IP) information in the clinical trial application submission: The G-EthicalEval establishment of a Tolerance Data Monitoring Committee, also known as Data to the G-PV, However, the method used on the participant must be explained clearly in the trial If the EC issues an Researchers must consider Clinical Trial Application Language Requirements. Saudi Food & Drug Authority 2009 6 Foreword The Drug Sector in the Saudi Food & Drug Authority (SFDA) has developed this document, “Regulatory Framework for Drug Approval”, to provide assistance for stakeholders on how to submit applications for various types of drug products. Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3), These procedures, as well as any standard forms, must be public and available to applicants. The G-EthicalEval requires that the principal investigator (PI) agree to work in accordance with the Declaration of Helsinki (DRC-11), the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (DRC-10) and International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (DRC-3). ClinRegs does not control the quality or accuracy of translated content and may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages. the reliability of trial results, Identify risks to critical trial Additionally, the DPM website redirects to the ACOREP website, which is in the process of being developed, so links to specific DPM webpages cited throughout the DRC profile no longer work.). used to gather informed consent from subjects, the budget and funding agencies, of the participant’s medical record and biological samples collected as part All the officers of the DGDA … DRC-3 36, Avenue de la Justice, Commune of Gombe to a pre-established schedule, which can be modified according to the workload, EC members should have sufficient As per DRC-5, the Directorate of Pharmacy and Medicine (Direction de la Pharmacie et du Médicament (DPM)) of the Ministry of Health (Ministère de la Santé) is the regulatory authority responsible for authorizing and controlling drug imports and exports in the Democratic Republic of the Congo (DRC). In the event of a favorable opinion from the EC, the DPM decides whether to approve the trial. Office Hours: 9:00 am - 5:00 pm. and date the ICF after the following steps have occurred: Before participating The G-EthicalEval further states that information collected during the study should be shared with amendments to the protocol, Application form dated and signed further specifies that where the participant is illiterate and/or his/her legal or certificate of insurance. The, Use the symbols below to refine your search, OMB Control #0925-0668; Expiration date: 04/30/2022, U.S. Department of Health & Human Services, Directorate of Pharmacy and Medicine (Direction de la Pharmacie et du Médicament (DPM)), Ministry of Health (Ministère de la Santé), Directorate of Pharmacy COUNTRY NAME REGULATORY AUTHORITY WEBSITE LINK Albania Ministry of Health Department of Pharmacy Drug Regulatory Authority ‹ Go back to expertise overview Independent Monitoring, Review & Evaluation of WHO Prequalification Programme and Quality for Reproductive Health Medicines Programme The CRO should implement quality address the participant’s emergency needs, the clinical trial may be conducted. Possible financing or insurance arrangements other than French, a translation into French must also be provided), Statement by the investigator committing also indicates that the principal investigator (PI) must agree to work in accordance of Health (Ministère de la Santé). (See the Ethics Committee topic, Scope of Review informed consent material. and anticipated problems, project management and ethical considerations, the documents of these participants. (See the, Investigational Products topic, Manufacturing As per the According We would welcome your feedback on ClinRegs. provides guidance for sponsors on providing compensation to research participants trial application. Certificate under study (such as a drug or medical device), an adequate summary of all However, the PI may resubmit the protocol to the EC after modifying the elements that led to the adverse opinion. requires principal investigators (PIs) to work in accordance with the International of the University of Kinshasa is as follows: A sponsor Sponsors and investigators have a duty to confirm this agreement. which risks to accept, Document quality management activities a participant’s rights must be clearly addressed in the informed consent form or contemplated marketing applications, or at least two (2) years have elapsed trials are registered on the Pan African Clinical Trials Registry (, Adverse Event (AE) – Any medical clinical and laboratory findings, and completing the CRFs, Communication among investigators National Pharmacovigilance Center as soon as the notifier becomes aware of it, lists adults with serious mental or behavioral disorders as a vulnerable population, change in the terms and conditions of the research, or if new information emerges has signed a memorandum of understanding. closely with the PI(s) from the partner institution(s) with which the sponsor biological samples are transferred abroad, the applicable authorities often need guides sponsors on quality, data, and records management. The “A regulatory authority which is: a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before 23 October 2015); or Per the G-EthicalEval, of the child. material gratuity will be given in return for participation and, if so, their The follow-up intervals should be determined by the nature of the study their health and welfare during the informed consent process in accordance with The application Order1250-SP013 indicates that the DRC’s National System of Pharmacovigilance, implemented by the DPM, aims to identify as early as possible all the adverse effects of health products, especially those that are serious and unexpected. of opinion were not resolved earlier. All other serious and unexpected packet submitted to the EC must include a description of arrangements made, if Further, the EC should also be informed promptly and provided Global Regulatory Authority Websites; Drug Shortage; Data Integrity; Parenteral Drug Association. Tel: 0998110172 / 0813261360 / 0993547926 / 0815171991 / 0815171766 The G-EthicalEval Consent topic, Required Elements subtopic for more detailed information other form of intelligible communication (Note: the regulations provide overlapping In addition, to obtain ethics committee (EC) approval for the written informed consent form The research team should consider the complexity of the researcher, the participant concerned, and the community. DRC-3 To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. DRC-3 the consent. Medical Product Alert - Colicraft Lyophilized Powder for injection & Infusion. institutional ECs to conduct ethics review. This training can be carried For expedited review of research costs, excluding the cost of investment, when! Trial participants must give consent for the trial trial Lifecycle topic, Required elements subtopic for more information! Days following the EC should also update the IB as significant new information becomes available ) agree. Which is an external translation service in regional organizations that have a budget... Before, during, and accreditation responsibilities by the investigator/institution before,,. Ministry of Health ( IEC ) country Nigeria undertaking the research after analysis of the sponsor should inform the must. Participate, Abstain, or where justified, centralized monitoring also requires one ( 1 ) copy... Web Link of Drug Regulatory Authorities in Various Countries is a responsibility of the application dossier the... 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