Drug Registration requirements for Pharmaceuticals in Emerging markets

Registration of pharmaceutical drug products in emerging market is maximum worrying task. Although the requirements are harmonized in regulated international locations by way of CTD (Common technical document) submitting, yet others have considerable diversity in necessities. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe collectively for various factors of drug registration. But there is no such harmonized guideline for rising marketplace besides Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exists in clusters with their mutual situation. Quality, Safety and Efficacy information has significance importance in dossier registration. Pharmaceutical Industries has to conform with regulatory requirement in Emerging market and for betterment of public Health and protection. The business importance of markets is increasing globally. It is important for pharmaceutical enterprise to address the regulatory necessities for betterment of public and to ensure their place in the marketplace. The review additionally explains a short approximately extraordinary regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier software in Emerging marketplace.

Regulatory Strategies for Orphan Drug Development in Canada – Australia

Canada, Australia have evaluated how their governments can facilitate the improvement of scientific merchandise to deal with uncommon issues. Each has hooked up programs and/or policies to help the improvement of merchandise to deal with unmet clinical wishes in small populations and to ensure their citizens get right of entry to such important medicines. Australia’s software, initiated in 1998, changed into evolved in collaboration with the United States Food and Drug Administration to facilitate the alternate and evaluation of facts on orphan tablets. Canada’s evaluation, posted in 1996, determined that a standalone orphan drug software became now not presently warranted, as present regulation and regulatory policies permit early get right of entry to critical medicinal merchandise. The incidences of such diseases were increasing at an extra pace than the speed with which drugs are researched and developed to treat such diseases. One of the fundamental motives is that the pharmaceutical enterprise is not very keen to research the improvement of orphan capsules as those capsules do no longer capture a larger market. This is the modern situation in-spite of the various incentives furnished in the orphan drug act. However, in this article, we’ve tried to focus on present regulatory framework, Current principles of rare sickness, Regulatory Challenges for Rare Disease Drug Development, Regulatory Integrated approach for the improvement and approval of orphan drugs in Canada & Australia.

Risk Assessment and Quantification in Manufacturing Enterprise

In this research first time in Latvia a multidimensional risk assessment is carried out in a manufacturing enterprise in the pharmaceutical industry according to the only international risk management standard ISO 31000:2018. The key multisided risks were identified and prioritized in the manufacturing pharmaceutical enterprise by applying the common metrics method: obtaining evaluations of risk occurrence and impact severity, made by the two highest levels of enterprise management, i.e. Board and senior line managers. A Top 10 of key risks was created from identified 64 different risks and the convergence and divergence in the risk rankings, evaluated by the enterprise’s Board and senior line management were obtained and analyzed. The main conclusion is that manufacturing enterprises in the pharmaceutical industry have specifics regarding exposure to multisided risks, where the main key risk is a regulatory risk and not different financial risks. Different rankings of enterprise operational risks, investment assessment risks, technological innovations risks made by the enterprise Board and senior line managers are signalling that exactly in these directions of the enterprise’s business activities it is necessary to review the strategic and operational planning with the aim to mitigate the potential risk impacts.

Information and analytical support for pharmaceutical production

Operation of modern pharmaceutical enterprise is impossible without information and analytical support providing prompt access to information, its analysis and the use of data for the functioning of enterprise. Structure of pharmaceutical enterprise includes divisions, which are often remote from each other. Centralized administration of their concerted activities, day-to-day communication, information transfer are important objectives of production meeting the requirements of international standards. Today, these issues are solved with the help of information technology providing collection and analysis of information necessary for sound management decisions and implemented on the basis of modern computer technology and modern means of communication.

AUTOMATED INFORMATION SYSTEMS AS ELEMENTS OF THE PHARMACEUTICAL ENTERPRISE QUALITY MANAGEMENT SYSTEM

Urgency of the research. With the development of information technology and new management practices, there has been a convergence and often a merger of quality management and information technology practices. At present, concepts based on the integration of quality management systems and automated information systems are becoming increasingly important.Actual scientific researches and issues analysis.In the process of researching specialized scientific and technical litera-ture, modern trends and problems of introduction of information technologies in the quality management system were analyzed.Uninvestigated parts of general matters defining. An unsolved problem is to ensure the quality of use of automated infor-mation systems at a pharmaceutical enterprise integrated into an enterprise quality management system based on the requirements of the international GMP standard and the Guidelines ST-N MOH 42-4.0: 2016 “Medicines. Good manufacturing practice".The research objective. The purpose is to systematically analyze the methodological foundations of quality assurance, through the introduction and use of AIS, aimed at creating favorable conditions for improving the efficiency of the quality management system in the pharmaceutical industry.The statement of basic materials. The issues of construction and improvement of quality management system based on existing technologies for automated production are considered. The structure of the computer quality management system and the mechanisms of its information support are determined. The methods of integration of specialized software systems are alsoanalyzed and the concept of integration of them into the quality management system is proposed.Conclusions.Based on the critical analysis, a number of unresolved problems related to the development, implementation and use of automated information systems based on international standards were separated, as well as the scientific hypothesis of the effective implementation and use of automated information systems integrated into the quality management system of the pharmaceutical enterprise was put forward.

SAFETY ASPECTS WITHOUT LOSS OF EFFECTIVENESS IN THE SWITCH OF PATIENTS WITH MULTIPLE SCLEROSIS FROM THE ORIGINAL DRUG GLATIRAMER ACETATE COPAXONE-TEVA ON THE BIOSIMILAR TIMEXON

The article presents the results of safety fi ndings during international multicenter randomized double-blind, active and placebo-controlled, comparative phase 3 trial. 158 patients with relapsing-remitting multiple sclerosis were randomly assigned into 3 groups: Timexon (glatiramer acetate, manufactured by JSC «BIOCAD», Russia), copaxone-Teva (Teva Pharmaceutical Enterprise Co., Ltd., Israel) and placebo, at a ratio of 2:2:1, respectively. At the second group 63 patients received Copaxone-Teva, after 48 weeks of therapy they received Timexon. Switching between therapy was not associated with adverse eff ect frequency. There was no clinically signifi cant diff erences in profi le and frequency of adverse eff ects between the groups of Copaxone-Teva and Timexon. Also, effi cacy analysis of therapy demonstrated no diff erences between timexone group and Copaxone-Teva group in both MRI parameters and frequency of relapses. The data obtained from the present study confi rm the equivalence in safety of Timexon (CJSC BIOCAD, Russia) and Copaxone-Teva, that is important for further implementation of glatiramer acetate generic in the clinical practice of multiple sclerosis therapy.