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Dr. Koteshwara K.B Professor, Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University,India.

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Dr. Mohd Shihabuddin B. A. Noorden Senior Lecturer Faculty of Pharmacy, Universiti Teknologi MARA, 42300 Puncak Alam, Selangor, Malaysia.

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Dr. Neeraj Kumar Fuloria Faculty of Pharmacy, AIMST University, Malysia, Malaysia.

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Dr. Rabi Bhatta Scientist Lab no: PCN-108 Pharmacokinetic and Metabolism Division CSIR-Central Drug Research Institute, Lucknow, India.

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Dr. Shashank K Singh Senior Scientist,CSIR-Indian institute of Integrative Medicine ,Canal Road Jammu, India.

Dr. Sridevi Chigurupati Senior Lecturer Faculty of Pharmacy, AIMST University, Malaysia.

Mr. Soh Yee Chang Faculty of Pharmacy UiTM Puncak Alam Campus Malaysia.

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Dr. V. Ravichandran Faculty of Pharmacy,AIMST University, Semeling - 08100,Kedah, Malaysia.

Mr. Viral Dineshchandra Jagiwala Assistant Professor, Shree Dhanvantary Pharmacy College, Surat, Gujarat, India.

Dr. Vivek Bhosale Scientist, Division of Clinical and Experimental Medicine CSIR-Central Drug Research Institute, Lucknow, India.

Dr. Waseem Rizvi Associate Professor Department of Pharmacology, J. N. Medical College, A. M. U, Aligarh, India.

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Dr. Sandip Prabhakar Zine Assistant Professor, Department of Pharmaceutical Chemistry, Vivekanand Education Society's College of Pharmacy, Mumbai, India.

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STM JOURNALS

I take the privilege to present the print version for the Volume 1 Issue (3) of Research & Reviews: A Journal of Drug Formulation, Development and Production. The intension of RRJoDFDP is to create an atmosphere that stimulates creativeness, research and growth in the area of Drug Formulation, Development and Production. The development and growth of the mankind is the consequence of brilliant Research done by eminent Scientists and Engineers in every field. RRJoDFDP provides an outlet for Research findings and reviews in areas of Drug Formulation, Development and Production found to be relevant for National and International recent developments & research initiative. The aim and scope of the Journal is to provide an academic medium and an important reference for the advancement and dissemination of Research results that support high level learning, teaching and research in the domain of Drug Formulation, Development and Production . Finally, I express my sincere gratitude and thanks to our Editorial/ Reviewer board and Authors for their continued support and invaluable contributions and suggestions in the form of authoring write ups/ reviewing and providing constructive comments for the advancement of the journals. With regards to their due continuous support and co-operation, we have been able to publish quality Research/Reviews findings for our customers base. I hope you will enjoy reading this issue and we welcome your feedback on any aspect of the Journal.

Dr. Archana Mehrotra Director STM Journals

Research & Reviews: A Journal of Drug Formulation, Development and Production

Contents

1. Drug Product Registration in US, EUROPE, JAPAN and CANADA for New Drug and Generics Thomas S., Dixit M., Charyulu R.N., Bengre P., Rao M.S. Shetty A

2. Marketing Authorization Procedure and Their Requirements for Pharmaceutical Products in European Union Rasheed A., Dixit M., Charyulu R.N., Rahman F., Daniel S.

3. Regulatory Requirement for Pharmaceutical Marketing in USA, EU and GCC: A Comparison Shetty A., Dixit M., Charyulu R.N., Bengre P., Rao M.S., Thomas S.

4. Pharmaceutical Drug Product Registration and Requirements in Latin American Countries Bengre P., Dixit M., Charyulu R.N., Shetty A., Rao M.S., Thomas S.

Research & Reviews: A Journal of Drug Formulation, Development and Production

ISSN: 2394-1944 (online) Volume 1, Issue 3 www.stmjournals.com

Drug Product Registration in US, EUROPE, JAPAN and CANADA for New Drug and Generics Thomas S.*, Dixit M., Charyulu R.N., Bengre P., Rao M.S. Shetty A Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical sciences, Nitte University, Mangalore, Karnataka, India Abstract Getting a marketing approval includes various junctures such as getting drug substances from approved vendors, finished product development, clinical studies, plant inspection, dossier writing and finally submission to authorities. US, Europe, Japan and Canada are the countries which are regulated for the approval of pharmaceutical products. These countries follow the ICH guidelines for the registration of drug of drug product. But each country has different type of application for the approval of new drug and generic drug. Europe follows different kinds of procedures for the approval of drugs. There is also difference in the duration required for the approval of drug to reach the market. Even though these countries follow harmonized procedures, it is impractical to get global marketing approval at same time and launch in all the regions at one go due to different type of applications and the different procedures. This article discusses the basic requirements for a drug product to reach the market.

Keywords: NDA, ANDA, PMDA, TPD

Research & Reviews: A Journal of Drug Formulation, Development and Production

ISSN: 2394-1944 (online) Volume 1, Issue 3 www.stmjournals.com

Marketing Authorization Procedure and Their Requirements for Pharmaceutical Products in European Union Rasheed A.*, Dixit M., Charyulu R.N., Rahman F., Daniel S. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India

Abstract Developing a new drug requires a great amount of research works in chemistry, manufacturing, controls, preclinical science and clinical trials. European Union (EU) is a hub of political and economic union of 28 member states (MS) and extensive amount of effort was spent by the EU Commission, the EU parliament, the European Medicines Agency (EMEA) and the national authorities in updating the EU regulatory environment for pharmaceuticals and granting marketing authorizations within the EU region. There are mainly three procedures by which a marketing authorization of pharmaceutical product in EU can be granted. Like 1. Centralized Procedure which is compulsory for any novel medicinal products and the subject to agreement by Committee on Proprietary Medicinal Products (CPMP), 2. Mutual Recognition Procedure (MRP) which commences only after a marketing authorization has been issued in any member state of EU, which then becomes the Reference Member State (RMS) and 3. Decentralized Procedure which came into force with the newly revised EU pharmaceutical Directive in November 2005 which is applicable in cases where an authorization does not yet exist in any of the EU Member States. However, Every EU country has their own registration process, which can be used by them when manufacturer wish to register their product in respective countries. However, if the European directive is completely implemented, the harmonization process appears difficult in consideration of the different social, political and economical characteristics of the different countries. Hence, the Main objective of this work is to understand the pharmaceutical product registration by different marketing procedures in European Union.

Keywords: European Union, National procedure, Centralized Procedure, Mutual Recognition Procedure, Decentralized Procedure

Research & Reviews: A Journal of Drug Formulation, Development and Production

ISSN: 2394-1944 (online) Volume 1, Issue 3 www.stmjournals.com

Regulatory Requirement for Pharmaceutical Marketing in USA, EU and GCC: A Comparison Shetty A.*, Dixit M., Charyulu R.N., Bengre P., Rao M.S., Thomas S. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India Abstract The Gulf Cooperation Council (GCC) pharmaceutical are known to be a semi-regulated market when compared with European Union (EU) and Unites States of America (USA) drug regulatory market. Product registration in GCC was challenging task in comparison to EU and USA due to lack of proper harmonised guidelines and diversity in registration procedure. The six GCC member states namely Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates have established a good regulatory guideline of their own, for drug marketing. Need for establishment of well-regulated guidelines is to ensure quality, safety and efficacy of drugs. The regulatory guidelines of EU and USA are standard for other regulatory agencies worldwide, and also to semi-regulated countries of GCC. This paper mainly focuses the various aspects of registration procedures, scope and time lines for the registration in USA, EU and GCC. A comparison between regulatory procedures of GCC with USA and EU countries will give us complete view on GCC countries being well regulated and emerging pharmaceutical market.

Keywords: United States Food and Drug Administration (USFDA), Gulf Cooperation Council (GCC), European Medicines Agency (EMA)

Research & Reviews: A Journal of Drug Formulation, Development and Production

ISSN: 2394-1944 (online) Volume 1, Issue 3 www.stmjournals.com

Pharmaceutical Drug Product Registration and Requirements in Latin American Countries Bengre P.*, Dixit M., Charyulu R.N., Shetty A., Rao M.S., Thomas S. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India Abstract The regulatory process to obtain marketing authorization’s (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly countryspecific. This article offers a practical overview of product registration processes in LATAM. Although the International Conference on Harmonization (ICH) Common Technical Document (CTD) can serve as a resource for most local MA applications, it is not necessarily required in its full length. Additionally, a significant amount of mandatory and highly country-specific documentation (related to infrastructure, legal documents, stability studies, labelling, etc.) require strategic planning and allocation for successful and timely local approvals. Exhaustive identification of actual requirements can present challenges due to frequent changes in regulations, unclear expectations, etc. Having as much early visibility and command of the LATAM country-specific requirements and health authorities’ (HAs) expectations will help the pharmaceutical industry to improve planning for global MA applications, optimally manage internal expectations, and most importantly give patients in the region faster access to therapies and better quality of life.

Keywords: Latin America (LATAM), Common Technical Document (CTD), Certificate of Pharmaceutical Product (CPP), Certificate of Medicinal Product (CMP), Chemistry, manufacturing and controls (CMC)