Pharmaceutical Regulatory Affairs: Open Access

Background: Globally and locally the pharmaceutical industry is highly regulated. In Albania the regulatory requirements are changing with different amendments of Low and Regulations to ensure the supply with high pharmaceutical quality, safety and efficacy of medicines. The accelerated procedure for medicines that come from EU/FDA, has given to the patients access to new medicines such as orphans and biosimilars in a very short time from their first marketing authorization. In this way the patient can achieve new pharmaceuticals which are safe, efficient and qualitative and the most important point innovative medicines that are authorized for marketing in USA and EU.

Methods and Results: Statistical data points indicate that in Albania from 2014 - 2018 are authorized for marketing: EU Centralized procedure 267 medicines and FDA 13 medicines, from 1666 authorized for marketing in total. From the remaining medicines, 1386 of them are from EU countries or West Balkans region. The trend of new medicines that are submitting at the Albanian Agency, from different pharmaceutical companies has increased from 2014 to present day, with new biosimilars, orphans and new medicines for acromegaly or antineoplastic agents.

Conclusion: In Albania we have an urgent need for regulations that govern interchangeability/substitutability of biosimilars, extrapolation of their indications, and new legislation on orphans. The purpose is to find common elements in the most varied regulatory systems that enable companies to identify the documents and information required by international regulators and understands technics that can help to reduce cost and time in the marketing authorization approval process globally. An analysis of the legislation of the different countries and an identification of the common elements must be discussed in a practical way.

Recommendations: Approaching the Albanian legislation with EU legislation regarding innovative medicines which can promote competition between different medicines for the same pathology reducing costs of therapy.

The miniaturized Near-Infrared Spectroscopy (NIRS) enables convenient, non-destructive and real-time testing of medicines that are circulating on the field or throughout the supply chain. We have successfully been able to detect falsified Viagra using a new low-cost, consumer-type NIRS. In like manner, we have distinguished the original Viagra from its generic versions with the same dose. This is a promising way of ensuring medicines authenticity by looking at their chemical ‘fingerprints’. Portable screening technologies for medicine quality assurance on the field or throughout the supply chain are currently growing and complementing the current approach for combating the falsified products, i.e., safety features on the packaging and laboratory analysis of suspect samples. In total, 78 spectra of Sildenafil-based tablets were recorded and classified using the K-Nearest Neighbors algorithm that relies on the Euclidean distances between measured values. Accuracy of our model was assessed using cross validation and bootstrapping techniques. In result, the miniaturized NIRS correctly ordered all tablets according to their manufacturer and indicated the falsified tablets, which spectra not only differed in shape from the authentic versions, but also show high spread in chemo-physical characteristics, which suggest poor manufacturing practices of the falsified products.