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.

scholarly journals REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND

2018 ◽  
Vol 3 (1) ◽  
pp. 62-74
Author(s):  
Achin Jain ◽  
Venkatesh M. P. ◽  
Raja Mohan Reddy.G ◽  
Pramod Kumar T.M.
Keyword(s):  
Generic Drugs ◽  
Pharmaceutical Products ◽  
Critical Parameters ◽  
Regulatory Environment ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
Registration Process ◽  
Drug Registration ◽  
Asean Countries

The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of medicines in their country. It not only includes the process of regulating and monitoring the drugs, but also the process of manufacturing, distribution, and promotion. The regulatory environment has similar characteristics, but drug registration requirements and processes differ among the countries. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. In ASEAN region, documentation can be filed in the ACTD format. Even though ACTD format is mandatory from 2009, the member countries have their own requirements for registration process like administrative documents, labeling. The purpose of this paper is to give a comparative overview on the Drug regulatory requirement for generics in two of the ASEAN countries which are Singapore and Thailand.

scholarly journals PACKAGING AND LABELING REQUIREMENTS OF PHARMACEUTICALS IN REGULATED MARKETS LIKE U.S.A. AND INDIA

2019 ◽  
Vol 8 (2) ◽  
Author(s):  
Sakshi Agarwal ◽  
Deepanmol Singh ◽  
Sandeep Kumar Voore
Keyword(s):  
Quality Control ◽  
Pharmaceutical Industry ◽  
Drug Product ◽  
Regulatory Requirements ◽  
Over The Counter ◽  
Regulated Markets ◽  
Labeling Requirements

In pharmaceutical industry packaging and labeling plays a very important role. This article provides an overview of regulatory requirements and tests for Quality control and suitability of packaging and labeling of prescription and Over-The-Counter (OTC) Products in USA and India. The study has been informative to understand the need and importance of the labeling requirements of pharmaceuticals to protect the consumers by providing the suitable instructions for the use of the drug product at suitable place and suitable format. KEYWORDS: Innovator, Generics, PLR (Physician Labeling Rule), OTC, FPL (Final Printed Labeling), Testing of packages, ANDA, Regulatory requirements, USA, India Market.

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.

A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

2020 ◽  
Vol 7 (3) ◽  
pp. 162-176
Author(s):  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
Vikas Rathee
Keyword(s):  
Regulatory Requirements ◽  
Health Value ◽  
Drug Products ◽  
Registration Process ◽  
Potential Market ◽  
Regulatory Guidelines ◽  
Cis Countries ◽  
In Cis ◽  
Regulatory Organization ◽  
Country Specific

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

scholarly journals Participation of Kazakhstan Pharmaceutical Companies in Global Value Chains Authors

2021 ◽  
Vol 17 (2) ◽  
pp. 473-485
Author(s):  
Elena D. Frolova ◽  
Zulparuza A. Abdurahkmanova ◽  
Alexander A. Ishukov
Keyword(s):  
Pharmaceutical Industry ◽  
Generic Drugs ◽  
Value Added ◽  
Global Value Chains ◽  
Value Chains ◽  
Pharmaceutical Companies ◽  
Enterprise Level ◽  
Micro Level ◽  
The Republic ◽  
National Economies

Growing interest of national economies in global value chains (GVCs) and the lack of micro-level research brought us to study the integration of countries in GVCs at the enterprise level (using the example of the pharmaceutical industry). We examine the situation in the Republic of Kazakhstan that is beginning to integrate into GVCs. Results of a questionnaire survey of the country’s pharmaceutical companies are considered along with public statistics. We developed a methodology to analyse the participation of a national entity in GVCs at the micro-level (including the enterprise participation in GVCs) and assess the performance of Kazakh pharmaceutical companies. The research is based on export and import data. A hypothesis on the participation of national pharmaceutical enterprises was partially confirmed: several surveyed companies participate in generic drugs GVCs at the production level, thus the value added is low. Features of pioneering entry into pharmaceutical global value chains for countries lacking such integration experience were demonstrated on a specific example. The obtained results can be used by countries starting the process of integration into pharmaceutical GVCs, as well as by Kazakhstan when developing the pharmaceutical industry.

scholarly journals Comparative Study on Counter-Piracy Activities of Japan and China

2012 ◽  
Vol 18 (3) ◽  
pp. 35-60
Author(s):  
박동형 ◽  
판보싱( 潘博星) ◽  
Ettehadi Saeid Reza ◽  
이종성
Keyword(s):  
Comparative Study ◽  
Japan And China

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.).

Sign in / Sign up

Export Citation Format

Share Document