Documentation Handling within the Polish Registration System
- PDF / 198,391 Bytes
- 3 Pages / 504 x 719.759 pts Page_size
- 43 Downloads / 209 Views
0092-8615/97
Copyright 0 1997 Drug Information Association Inc.
DOCUMENTATION HANDLING WITHIN THE POLISH REGISTRATION SYSTEM ANDRZEJCZARNECKI, MD, PHD, DSc Director, Central Register of Clinical Trials, Drug Institute, Warszawa, Poland
The request for marketing authorization in Poland has to be submitted to the Bureau for Registration of Pharmaceutical and Medical Materials on the “Applicationfor Pharmaceutical Product Registration. ” All documentation to be provided, in either Polish or English, is specified in the application form and includes experts’ reports. The procedure is tiered. The dossier is divided into three areas of expertise: chemistry and pharmacy, pharmacology-toxicology and clinical medicine, and drug information. The final report, consisting of summaries of the area reports, is scrutinized by the Registration Commission. Subsequently,following a positive decision the drug enters the process of quality testing and further documentation assessment. When the final assessment is ready, the Registration Commission makes a decision on registration. If the Registration Commission decision is negative an appeal may be submitted to the Minister of Health and Social Welfare by the applicant within 14 days. In general, the documentation is being processed on paper: Nevertheless, there are two existing databases: clinical trials and drug information. DAMOS, a registrational regulatory software package, is now being implemented in the registration system. Key Words: Documentation; Poland; Registration; Pharmaceuticals
THE DECREES REGULATING registration of pharmaceuticals in Poland are based on European Community Directives. Nevertheless, the Polish registration system is still less organized and more complicated. It consists at present of three bodies: the Ministry of Health and Social Welfare (MoH), the Registration Commission (RC), and the Bureau for Registration of Pharmaceuticals and Medical Material (BRP). According to the Polish Law of 1991, the body entitled to prepare and make decisions on registration of pharmaceuticals and medical materials is the Registration Commission (1). This consists of a
number of specialists in different fields of medical sciences appointed by the Minister for five-year terms. The final decision on marketing authorization is signed by the Ministry of Health and Social Welfare following the recommendation of the RC. Such a system has certain drawbacks (2). The change in market regulations to a free market economy at the end of the 1980s created a long backlog and delays counted in years in the registration system. Therefore, in 1993, the Bureau for Registration of Pharmaceuticals and Medical Materials was created. It started serving as a Secretariat to the RC. With time, certain expertise in evaluation of documentation was develPresented at the DIA 8th Euromeeting, May 5-8.1996, oped and most of the work is now being done Copenhagen, Denmark. Reprint address: Professor A n h j Czamecki, Drug by BRP. Final documents are presented at Institute. Chehnska 30/34, PL-00 725 W
Data Loading...
