Setting up an official medicines control laboratory

Abstract

An Official Medicines Control Laboratory (OMCL) is an independent public laboratory that analyses the quality, safety, and efficacy of medicinal and non-medicinal products such as packaging, diagnostic products, medical devices, food supplements, cosmetics, and tattoo inks. Each OMCL is part of the General European OMCL Network (GEON), where OMCLs share resources and expertise to support regulatory and scientific advancements through ISO accreditation of harmonised standards. The study aimed to investigate the setting up of an OMCL and the running of the laboratory regarding the resources, including equipment, technical skills, personnel, and finances. A questionnaire was developed and validated by six experts. The questionnaire was then disseminated to 71 OMCLs by the EDQM. To further support the need for an OMCL in Malta, a review and summary of the needs assessment and cost-benefit analysis report from the Malta Medicines Authority and available OMCL annual reports were done. The compiled reports and questionnaire data were compiled and analysed. Establishing a local OMCL in Malta will effectively and efficiently service the country by filling the gap of foreign laboratories that service the local authorities and private operators. Hence, decreasing the cost and timeframe of samples to be tested while maintaining the quality of the sample and the result. Moreover, the reports showed that establishing a local OMCL is feasible and beneficial. The developed questionnaire can be used as a basis for a further feasibility study in defining and justifying the need for an OMCL in Malta. In conclusion, a local OMCL benefits Malta, locally and internationally, through the different collaborations. The local OMCL can protect public health by ensuring the safety and efficacy of medicines and medical products by ensuring the quality of products before and after it is on the market. Additionally, a local OMCL can cater for the opportunities Malta had missed, such as the batch release of Covid vaccines.