scholarly journals Situation of Pharmaceuticals in Albania 2014-2018

2020 ◽  
Vol 6 (2) ◽  
Author(s):  
Mallkuci I ◽  
Sinani N ◽  
Thereska I
Keyword(s):  
Pharmaceutical Industry ◽  
Marketing Authorization ◽  
Regulatory Requirements ◽  
Safety And Efficacy ◽  
Pharmaceutical Quality ◽  
Short Time

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.

scholarly journals PHARMACEUTICAL QUALITY AUDITS: A REVIEW

2019 ◽  
Vol 11 (1) ◽  
pp. 14
Author(s):  
Princy Agarwal ◽  
Amul Mishra
Keyword(s):  
Quality Assurance ◽  
Pharmaceutical Industry ◽  
Pharmaceutical Company ◽  
Search Engine ◽  
Quality System ◽  
Vital Function ◽  
Regulatory Requirements ◽  
Reimbursement Mechanisms ◽  
Quality Audit ◽  
Pharmaceutical Quality

Auditing is a vital function within a pharmaceutical company nowadays. Quality audit is a review and evaluation of all or part of a quality system with the specific purpose of improving it. It is one of the means to examine pharmacy programs and ensures that the procedures and reimbursement mechanisms comply with the contractual and regulatory requirements. A quality audit is usually conducted by external or independent experts or by a team designated by management for this purpose. These audits can be extended to suppliers and contractors as well. An audit will assess the strengths and weaknesses of quality assurance and quality assurance processes, the results of which assists in improving processes and building a better system for company benefits. This article focuses on various aspects of quality auditing in the pharmaceutical industry including its principles, objectives, importance and benefits and planning along with the deficiencies that are likely to occur during the process. This review comprises a well-organized summary of various guidelines available till date using the Google Scholar search engine and the keywords listed below.

scholarly journals COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA

2018 ◽  
Vol 3 (1) ◽  
pp. 75-87
Author(s):  
Dinesh Chandra Konuri ◽  
Mamillapalli S. ◽  
A. Elphine P. ◽  
Brahma S.R. Desu
Keyword(s):  
Pharmaceutical Industry ◽  
Comparative Study ◽  
Generic Drugs ◽  
Emerging Market ◽  
Generic Product ◽  
Regulatory Requirements ◽  
Registration Process ◽  
Regulated Markets ◽  
Device Agency ◽  
Japan And China

A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study covers the introduction to generic drugs, and JAPAN & CHINA regulatory authorities. It also includes the requirements and registration of Generic Drugs in above specified countries. It also includes the checklist for comparative study of regulatory requirements and registration process of generic drugs in JAPAN & CHINA. JAPAN and CHINA are two different markets which are important to pharmaceutical industry. Japan is under one of the Regulated markets and owning the world’s second largest pharmaceutical market. Whereas China is under the Emerging market, but unfortunately these two are un trapped markets in the Pharma hub. So, am enthusiastic to know about Regulatory considerations and Registration process of Generic Drugs.

11. The Regulation of Medicines

Medical Law ◽  
2019 ◽  
pp. 573-624
Author(s):  
Emily Jackson
Keyword(s):  
Consumer Protection ◽  
Strict Liability ◽  
Marketing Authorization ◽  
Safety And Efficacy ◽  
Consumer Protection Act ◽  
European Harmonization ◽  
Academic Debate

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate; providing students with a stand-alone resource. This chapter examines the regulation of medicines. It first explains what a medicine is and the need for it to have a marketing authorization before it can be put into circulation. It covers the importance not only of establishing safety and efficacy before licensing, but afterwards as well, through pharmacovigilance mechanisms. The chapter covers the increasing European harmonization of the rules covering the licensing and marketing of medicines, and briefly discusses the implications of Brexit. Finally, it looks at liability for defective medicines, and the strict liability regime under the Consumer Protection Act.

scholarly journals Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance

2020 ◽  
Vol 11 ◽  
pp. 204209862090961
Author(s):  
Marina A. Malikova
Keyword(s):  
Pharmaceutical Industry ◽  
Health Professionals ◽  
Case Reports ◽  
Individual Case ◽  
Regulatory Requirements ◽  
Practical Applications ◽  
Safety Alert ◽  
Potential Safety ◽  
Post Marketing ◽  
Regulatory Decisions

Pharmacovigilance is a field where communication is crucial, and exchange of information is expected to be done in a timely manner. Information from individual case reports is transmitted from pharmaceutical industry and health professionals to the regulatory authorities. The safety profile of a drug is established by analyzing individual cases and aggregate reports. The cumulative information, obtained from these reports, can be used to assist pharmacovigilance professionals in the detection of potential safety signals by monitoring evolving trends. If there is a message identifying concern as potential safety signal, the transmission of individual case reports, as well as cumulative and aggregate reports will occur from pharmaceutical industry to the regulators; and based on their assessments of causality in relationship to the drug, the regulatory decisions will be made. Once regulators confirming a signal as a possible safety alert have made the decision, the decisions and the reasons must be communicated to health professionals, the pharmaceutical industry, and other parties involved (e.g. clinical trials participants, investigators, consumers and medical professionals at post-marketing stage, etc.).

Partnership Efforts – Their Potential to Reduce the Challenges that Confront Regulators and Pharmaceutical Industry

2019 ◽  
Vol 6 (1) ◽  
pp. 7-17 ◽  
Author(s):  
Sandeep Kumar Dhiman ◽  
Vikram Gummadi ◽  
Harish Dureja
Keyword(s):  
Pharmaceutical Industry ◽  
Citizen Participation ◽  
Product Life Cycle ◽  
Scientific Discovery ◽  
Life Cycle Management ◽  
Regulatory Framework ◽  
Healthcare Sector ◽  
Unique Contribution ◽  
Safety And Efficacy ◽  
Development Costs

Background: The healthcare is a highly regulated sector as it serves billions of population globally. The two imperative pillars of this sector are pharmaceutical industry and health regulatory authorities. While the industry acts as a supplier in this sector, regulators provide governance to ensure quality, safety and efficacy of the healthcare products. Even though organizational objectives of these two stakeholders are different, the by and large goal is to improve health outcomes for populations. Both these entities are confronted by an assortment of challenges. Objectives: This study aims to draw attention towards such pain points and the potential of collaboration and coordination efforts between these entities to mitigate these challenges. The industry faces challenges that are driven by business needs and regulations. The major challenges faced by the regulators are driven by the needs to ensure the safety, quality and efficacy of health care products. Some of these challenges may have an overlap. Market scenario, patent/ exclusivities/return on investment issues, development costs, cost containment, quality and GMP, scientific discovery productivity, novel therapies and technology, regulatory framework, counterfeiting, supply chain challenges, Product life cycle management (PLM), patient centricity approach, resources and financial constraints, process issues, protection of the public health, contemporizing and growth of regulatory framework, political scenario in the country/region, unethical clinical trials and research, healthcare policies, citizen participation, pharmacovigilance and safety measures comprise a non-exhaustive list of challenges that confront industry and regulators. Health authorities need to partner amongst them and with Pharmaceutical industry and continue to innovate for novel ways of working to conquer these challenges. Organizations of international/ regional repute are known for their unique contribution in regulating the healthcare sector. These bodies have helped to improve access to safe medicines more widely by harmonization of drug quality, safety, and efficacy standards. These coordinated efforts have the potential to reduce the numbers of challenges that confront the healthcare sector. Conclusion: The pharmaceutical industry and health regulators need to partner to achieve common goal of healthcare. There is a growing need for these parties to come together on common platforms and collaborate. The success of the strategies and approaches intended to deal with these challenges depends upon strategic-level leadership and new ways of collaborative working, which creates a room for potential synergies.

The Impact of Information Systems on Management Performance in the Pharmaceutical Industry

2015 ◽  
Vol 17 (3) ◽  
pp. 56-73 ◽  
Author(s):  
Sherif Elshorbagy ◽  
Lalit Garg ◽  
Vipul Gupta ◽  
Gopalakrishnan Narayanamurthy ◽  
Yosuf Abd Al Oraini
Keyword(s):  
Pharmaceutical Industry ◽  
Pharmaceutical Companies ◽  
Successful Implementation ◽  
Strategic Decisions ◽  
Management Performance ◽  
Business Operations ◽  
Lack Of Information ◽  
Short Time ◽  
And Control ◽  
The Impact

There are many aspects that should be considered while implementing ISs in pharmaceutical companies. This is due to the various regulations and standards that the governmental authorities impose on these companies. In addition, any audit from US Food and Drug Administration (FDA) or other authorities will require computer system validation to be performed for the implemented ISs to ensure that all areas that affect the drugs lifecycle are following the required standards, and that each single process in this lifecycle is validated. Unfortunately, many pharmaceutical companies didn't recognize yet the importance of ISs to their businesses. The research presented in this paper examines the value of using an information system (IS) in pharmaceutical environment and how it can be a key component of improving the operational and process effectiveness by supporting the strategic decisions and enabling the decision-makers to take their decisions in short time. Lack of information in pharmaceutical companies is one of the reasons why these companies will not be able to compete in this competitive market because the delays in taking decisions, product lifecycle, and supply chain. Pharmaceutical companies required to follow various regulations and standards, and ISs are the tools that can be mapped to these standards and control the business operations without any obstacles. The authors conducted a comprehensive study to investigate the role of ISs in the pharmaceutical industry through a review of existing literatures relevant to the research subject and through a questionnaire survey with 54 participants working in the pharmaceutical industry in different countries in the Middle East. The survey aimed to understand the present status of ISs in pharmaceutical companies and the impact of ISs on management performance, operation improvement, end-users productivity, and compliance with the regulations and standards of the pharmaceutical industry in their companies. Moreover, the survey also aimed to identify the catalysts behind successful implementation of ISs.

scholarly journals Risk Management in the Pharmaceutical Industry in Slovenian Companies

2017 ◽  
Vol 8 (1) ◽  
pp. 42-49 ◽  
Author(s):  
Nina Bucalo ◽  
Borut Jereb
Keyword(s):  
Risk Management ◽  
Supply Chain ◽  
Pharmaceutical Industry ◽  
Pharmaceutical Companies ◽  
Regulatory Requirements ◽  
The World ◽  
High Level ◽  
The Cost ◽  
Effective Assessment ◽  
World Supply

Abstract The pharmaceutical industry is one of the most competitive businesses in the world. Supply chain in this industry has been directed towards the production of large batches to avoid lack of supplies, and the achievement of regulatory requirements, at the cost of high level of inventory, higher costs and inventory write-off due to expiration or other reasons. In recent years this industry is facing major changes and challenges such as intense globalization processes, increased competition and innovations in technologies, which has broadened and deepened risks in supply chain. The paper reports the results of the study of the risk in distribution processes of Slovenian pharmaceutical companies, which was conducted among five companies and aims to draw attention to risks that arise in supply chain, to emphasize the importance of their management and to present a model for an effective assessment of risk in companies, developed at the Faculty of Logistics.

scholarly journals A New Drug Approval Process in Europe: A Review

2019 ◽  
Vol 7 (3) ◽  
pp. 21-29
Author(s):  
Krishnasis Chakraborty
Keyword(s):  
Drug Approval ◽  
New Drugs ◽  
Marketing Authorization ◽  
Approval Process ◽  
Regulatory Requirements ◽  
New Drug ◽  
Regulatory Affairs ◽  
Drug Approval Process ◽  
Marketing Authorization Application

Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and Regulatory requirements according to European Medical Agency (EMA) (1).

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