REGULATORY REQUIREMENTS AND APPROVAL PROCESS FOR MEDICAL DEVICE IN JAPAN, AUSTRALIA AND BRAZIL

2018 ◽  
Vol 10 (03) ◽  
Keyword(s):  
Medical Device ◽  
Approval Process ◽  
Regulatory Requirements

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

scholarly journals A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

2017 ◽  
Vol 1 (04) ◽  
pp. 133-146
Author(s):  
Krishna Madagoni ◽  
Uppunuri Saidireddy ◽  
Himaja .
Keyword(s):  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Technical Documentation ◽  
Regulatory Requirements ◽  
Regulatory Decision ◽  
New Drug ◽  
Regulatory Affairs ◽  
Regulatory Approach ◽  
Drug Approval Process

Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (RandD) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process and requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.

Cultural Barriers to the Transition from Product to Product Service in the Medical Device Industry

2014 ◽  
Vol 5 (2) ◽  
pp. 36-50 ◽  
Author(s):  
Linda Ryan ◽  
David Tormey ◽  
Perry Share
Keyword(s):  
Medical Device ◽  
Value Chain ◽  
Service Provision ◽  
Cultural Barriers ◽  
Manufacturing Companies ◽  
Regulatory Requirements ◽  
Product Service ◽  
High Level ◽  
Product Service Systems ◽  
Service Transition

Manufacturing companies are increasingly moving up the value chain by expanding their value offering to include service components, namely Product Service Systems (PSS). Due to the fundamental differences between the provision of products and services, many struggle to effectively integrate the two into a single cohesive offering. This is particularly true of companies operating in the medical device field as, due to the high level of regulatory requirements and controls, implementation of the ‘soft' components of service provision is difficult. The aim of the research is to facilitate companies to move up the value chain from product to product-service provision. Once identified, barriers can then be directly addressed and overcome, thereby allowing the development of a cohesive PSS offering. This will be achieved by identifying existing cultural barriers in relation to the application of PSS strategy within a product-orientated business. This information can be used to facilitate the application of PSS models with produc-orientated companies. This paper details qualitative research, undertaken with eight product-orientated medical device companies and two service practitioners, which establishes, details and analyses the primary cultural barriers in relation to product to product-service transition. These cultural barriers are further extrapolated through a supporting literature research.

scholarly journals MDUFA and its Impact on Medical Device Sector

2020 ◽  
Vol 11 (2) ◽  
pp. 2109-2116
Author(s):  
Anjana B ◽  
Naga Gouri T ◽  
Pramod Kumar T M ◽  
Venkatesh M P
Keyword(s):  
Medical Device ◽  
Review Process ◽  
Approval Process ◽  
Patient Health ◽  
Device User ◽  
User Fee ◽  
Set Up ◽  
Short Time ◽  
To Receive ◽  
The U.S

The U.S. Congress passed Medical Device User Fee Act (MDUFA), where FDA is required to assign and collect fees from manufacturers of medical devices to evaluate the functioning and the usage of the device.  for the purpose of fastening the analysis of the application of the drug. The Medical Device User Fee Modernization Act was first adopted in 2002. The act focussed on innovative review process and reviewing capabilities of experts. Every five years, MDUFA comes up with reauthorisation. The act was reauthorized in 2007 by reducing the application fee and introducing certain new fees such as the annual product fee and annual establishment fee which helped in pre-market evaluation. Few issues being raised in MDUFA II led the congress to enact an amendment. The next revision of the act made the review process more efficient and interactive with the applicant to meet the timelines. Recent amendment has set up several new performance goals and proposes certain changes to the previous amendments. The device manufacturers are currently in a position to receive regulatory approval in a short time compared to the pre-MDUFA period. MDUFA has helped in improving the patient health by streamlining the FDA’s approval process for application of new medical device, thereby allowing patient’s quicker access to potentially life changing therapies.

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).

scholarly journals Biosimilars: Are They Ready for Primetime in the United States?

2011 ◽  
Vol 9 (8) ◽  
pp. 934-943 ◽  
Author(s):  
Bradford R. Hirsch ◽  
Gary H. Lyman
Keyword(s):  
United States ◽  
The United States ◽  
Pharmacokinetic Parameters ◽  
The European Union ◽  
Approval Process ◽  
Regulatory Pathway ◽  
Regulatory Requirements ◽  
Economic Implications ◽  
Ensure Patient Safety ◽  
Critical Issues

The introduction of alternative versions of biologic products, also known as biosimilars, into the United States market has been gaining increasing visibility as patents for many agents are nearing expiration. Unlike generics, which are regulated under the Hatch-Waxman legislation passed in 1984, the approval process for biosimilars in the United States has not been defined. In 2004, the European Union established a regulatory pathway for these agents, and the FDA is now following suit. The economic implications are large, with $66.9 billion spent on the top 20 biologics in 2009. Of the top 10 biologics, 6 are routinely used in oncology. As the regulatory requirements are debated, several critical issues must be resolved. The most obvious is that the agents must be shown to be comparable to the original biologic they intend to replace. Knowledge of pharmacokinetic parameters alone will not be adequate, but the amount of clinical data required by the FDA remains unclear. The regulations will define the ease with which a biosimilar can be brought to market, and the associated costs of trials will influence the ultimate price of the medications. Balancing the needs of the relevant stakeholders is critical to ensure patient safety while controlling costs, improving access, and encouraging innovation. This is not an easy balance to strike.

scholarly journals Analysis: Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices

2020 ◽  
Vol 54 (3) ◽  
pp. 178-188
Author(s):  
Teresita C. Liebel ◽  
Tara Daugherty ◽  
Alexandra Kirsch ◽  
Sharifah A. Omar ◽  
Tara Feuerstein
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Database Systems ◽  
Regulatory Requirements ◽  
User Facility

Abstract This article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for each. Manufacturers can leverage the suggested practices described in this article to address regulatory requirements.

A Perspective on the FDA Premarket Approval Process

1987 ◽  
Vol 110 ◽  
Author(s):  
John L. Ely
Keyword(s):  
Medical Device ◽  
Implantable Devices ◽  
Process Time ◽  
Approval Process ◽  
Successful Completion ◽  
Medical Products ◽  
The Law ◽  
The Relationship ◽  
Premarket Approval

AbstractPremarket review processes as prescribed by the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act greatly affect the use of materials in medical products, especially for implantable devices. The premarket approval process can have a particularly important role in eventual commercial medical uses of materials. Managing the process properly is often critical to the success or failure of a product.A review of the law and regulations as they pertain to premarket approval is presented. Subjects included in this overview are prediction of process time and costs, examination of potential pitfalls in the process, recommendations on organizing for successful completion of the process and handling the relationship with FDA.Specific materials related issues that are likely to arise are noted.

Review of U.S. Medical Device Regulation

2007 ◽  
Vol 1 (4) ◽  
pp. 283-292 ◽  
Author(s):  
Jan B. Pietzsch ◽  
Lauren M. Aquino ◽  
Paul G. Yock ◽  
M. Elisabeth Paté-Cornell ◽  
John H. Linehan
Keyword(s):  
Medical Device ◽  
The United States ◽  
Careful Consideration ◽  
Practical Implementation ◽  
Design Development ◽  
Regulatory Requirements ◽  
Regulatory Pathways ◽  
Device Development ◽  
Federal Food ◽  
Medical Device Regulation

Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. In this paper, we review the background, mission, and statutory requirements of medical device regulation in the United States. As opposed to pharmaceuticals, which have been regulated since the early 1900s, medical device regulation was not enacted before 1976, when Congress signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1938. The U.S. Food and Drug Administration (FDA) has implemented a risk-based classification system, which is essential in determining the regulatory pathway for a given device. Our review of the different regulatory pathways discusses the specific steps and requirements associated with each pathway, and their implications for development and testing of different types of devices. The differences in these pathways are significant, and thus require careful consideration and analysis already at early stages of development. The FDA’s Quality Systems Regulation, which outlines specific requirements for development, testing, production, and postmarket surveillance, is another important aspect of device regulation. We present its elements and relationship to design controls and other operating procedures implemented by device manufacturers, and discuss their relevance in ensuring the safety and effectiveness of marketed devices. A summary of recent additions to device regulation, implemented by the FDA to allow for adequate regulation of products that combine drugs and devices or biologics and devices (so-called combination products), completes our review. Because of the significance of device regulation for medical device innovation, we strongly support increased efforts to educate the various stakeholders involved in the medical device development process, both at the academic and professional level.

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