H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Scientific and regulatory advice

Scientific advice on new drug development

Our scientific advice service for drug development covers support for pharmaceutical quality, as well as for non-clinical and clinical developmental issues. Our complex developmental assistance is provided by expert professionals including pharmacists, chemists, bioengineers, biologists, medical professionals and biostatisticians. Consultancy covers the interpretation of directives/regulations and quality guidelines for medicinal products, as well as support for the design of non-clinical studies. Regarding clinical studies, we give expert opinion on pharmaceutical quality requirements and relevant quality issues, as well as on the appropriateness of accomplished non-clinical and clinical studies. The scope of consultancy covers the assessment of whether the available scientific data are sufficient for the actual study in point, and we also assess the study protocol for executability.

Scientific advice on pharmacovigilance issues

Scientific advice on pharmacovigilance issues related tonew drug developmentincludes the assessment of safety data presented by the applicant. We answer the applicant’s questions on pharmacovigilance, concerning the risk management plan (RMP), risk minimisation measures, drug safety and efficacy studies.

Scientific advice on pharmacovigilance related tonew drug approvalsincludes consultation on post-authorisation pharmacovigilance activity issues (e.g. concerning the RMP, risk minimisation measures and their national implementation, drug safety studies, drug utilization studies, efficacy studies). Consultancy on changing prescription status (ie. on re-categorizing a medicinal product as a non-prescription [OTC] medicine) is also available.

We provideassistance to the interpretation of regulations, as well as withdefining requirements and obligations in individual cases. Hereby we offer help with the correct interpretation of specific requirements for individual cases, as defined by national and international laws and regulations including directives and standards specified by OGYÉI.

Scientific advice related to applications for marketing authorisation

Scientific advice related to applications for marketing authorisation includes giving expert opinion on the legal basis of a proposed application for new drug approval. The scope of expert opinion covers areas such as evaluating a proposed brand name, packaging and proposed marketing activity. Consultancy on presumed or proven drug quality discrepancies and failures is also available.

Scientific advice on quality assurance systems

The Inspectorate Division of OGYÉI is committed to maintain close co-operations with the stakeholders of the pharmaceutical industry in order to guarantee a constant improvement of the safe drug supply chain. Therefore, our inspector colleagues with wide-scale international experience are not only engaged in inspections, but also in assisting all partners of the OGYÉI. We give information on our activities related to regulatory issues (concerning drug manufacturing and wholesale trade) and to inspectoral affairs (concerning preclinical and clinical studies and pharmacovigilance). We provide guidance on quality assurance systems (GLP, GCP, GMP, GDP, GVP) related to the development, manufacturing, distribution and pharmacovigilance of drug substances and medicinal products. We are committed to provide assistance in solving any problems arising in everyday pharmaceutical practice.

Consultancy on health-economical issues

The Division of Health Technology Assessment of OGYÉI offers consultancy on methodological issues related to health-economical analyses. Our consultants are medical referees and health-economical analysts. The discussion helps to eliminate uncertainties and promotes the elaboration of relevant analysis papers that support decision-making.

Scientific advice on medical devices

Our scientific advice service on medical devices is aimed to give assistance to concerned stakeholders (manufacturers, distributors, importers, resellers) and healthcare service providers. The scope of consultancy includes the issues of legal market introduction and trade of medical devices. We provide assistance with clinical studies to support the efforts at study sites. Besides, we give expert opinion on issues regarding qualifications for medical devices.

Consultancy on issues dedicated to the Chief Pharmaceutical Division of OGYÉI

Consultancy on the appropriateness of pharmacy-specific software includes a comprehensive task-specific and legal assessment of authorized software utilized in community and clinical pharmacies. Regarding task-specific appropriateness we are engaged in giving advice on software development including guidance on possible solutions and options for implementation.

Our evaluation and advice service on IT development and application issues support state-of-the-art IT solutions and e-health applications under development, aiming to improve medication adherence and therapeutical outcomes. Consultancy involves IT specialists, pharmacists and economists. This multidisciplinary co-operation serves the efficient and successful realization of modern IT developments.

Our evaluation and advice service on automated systems of drug supply includes the assessment of automated logistic systems utilized or planned to be utilized in community and clinical pharmacies. Besides giving expert opinion on these systems and their appropriateness, we offer support to their successful on-site introduction and adaptation.

We offer support to the implementation of novel developments related to specific clinical pharmacy activities and so-called non-professional clinical pharmacy activities (e.g. those related to parenteral mixtures of solutions for infusion, cytostatic mixtures of solutions for infusion, unit dose systems, clinical studies, medicines of individual financing). Consultancy covers the evaluation of adequacy and agreement with professional guidelines, and is based on the coherence of all relevant legal, methodological and adequacy considerations.

Last updated: 2021.06.10 15:54