Legislation & resources needed as Croatia prepares to join EU
Croatia has adopted EU policy into national legislation but in this pre-accession period there are discrepancies in the roles of pharma companies and regulators. Writing in Archives of Industrial Hygiene and Toxicology Croatian regulators analyse their role in drug production and quality.
Inspection of pharma production facilities is an area where Croatia can improve, according to the paper. Currently responsibility is split between the Ministry and Agency for Medicinal Products and Medical Devices but the authors believe this complicates administrative processes.
“If GMP inspection were to become the agency’s responsibility, certain administrative and other decisions would be easier to make, because the agency has complete documentation about medicines and production and experts to evaluate medicinal products”, says the report.
Revisions to legislation would also help regulators. Globalisation of active pharmaceutical ingredient (API) production has increased the need to conduct inspections in third-countries. To support regulators the paper calls for additional provisions to define inspection of API producers.
Adoption of new legislation and regulatory approach will make it “increasingly important to produce well trained inspectors”, according to the paper. Consequently, resources will be needed to train and employee sufficient inspectors.
Information exchange
Collaboration with the EU can support training. Croatian inspectors participate in some meetings of the European Medicines Agency’s (EMA) GMP Inspectors Group and EudraGMP Telematics Group but would benefit from increased field training with peers in the EU.
Furthermore, becoming a member of the Pharmaceutical Inspection Convention and Co-operation Scheme (PIC/S) would support mutual exchange of information and resources.
Becoming a full member of the EU will also increase exchange of information and resources. Consequently, accession will give a new boost to our fight against pharmaceutical counterfeiting as a global problem and to our strivings to protect patients”, says the report.
