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  • 11
    Online Resource
    Online Resource
    Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD)
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 6, No. 2 ( 2018-06-15), p. 67-71
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 6, No. 2 ( 2018-06-15), p. 67-71
    Abstract: Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical companies to prepare single dossier that can be simultaneously submitted in many countries for approval. In all countries there is a similar characteristic in regulatory environment but there is a difference in their registration requirements. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Malaysia. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v6i2.245
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 12
    Online Resource
    Online Resource
    Regulatory requirements for the approval of Anti-Cancer drug (Mercaptopurine) in Myanmar as per ACTD
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 6, No. 2 ( 2018-06-15), p. 35-40
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 6, No. 2 ( 2018-06-15), p. 35-40
    Abstract: South East Asian pharmaceutical market is growing rapidly. In Asian country, The regulatory environment is similar among all countries. But still requirements and process of registration is varying among countries of Asian region. Although ACTD is harmonized for all ten countries but still every country differ in some of the local requirements such as administrative, technical, clinical and non clinical documents. Among this country Myanmar systematically regulate the manufacture, import, export, storage, distribution and sale of drugs. Aim of the present study is To discuss emerging challenges and requirements posed by compulsory licensing for drugs in diseases such as cancer. In this article we have observed documents requires for registration of Mercaptopurine drug belonging to anti – cancer category in Myanmar. Documents like batch manufacturing record, process validation records, stability study which include long term and accelerated stability studies as per zone specification of Myanmar, packing requirements for anti – cancer drug and certificate for product permission required for registration, which has covered all aspects from manufacturing to its packing and registration. This article will give the easy understanding on the drug registration requirements for anti – cancer drug such as Mercaptopurine in Myanmar.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v6i2.235
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
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  • 13
    Online Resource
    Online Resource
    REGULATORY REQUIREMENTS FOR DRUG PRODUCTS REGISTRATION IN SOUTH AFRICA
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 4 ( 2018-02-13), p. 1-8
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 4 ( 2018-02-13), p. 1-8
    Abstract: The South African Pharmaceutical market is one of the emerging markets in the world and it is important to study on how to register a drug in the promising pharmaceutical market in Africa. The MCC is the regulatory body which deals with the quality, safety and efficacy of the medicines in South African market which regulates by approving the medicines by very specific process which is unique to South African health system. They have a specific type of CTD for Regulatory submissions which is generally well known as ZA CTD. This article provides the insight on the Drug Registration process in South Africa, the details of data to be submitted to the agency and the pathways of registration an applicant can avail, categories a drug can be registered by MCC, Application fees to be paid to the agency on various types of applications are also dealt.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i4.171
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
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  • 14
    Online Resource
    Online Resource
    DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE
    Society of Pharmaceutical Tecnocrats ; 2015
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 2 ( 2015-06-06), p. 1-7
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 2 ( 2015-06-06), p. 1-7
    Abstract: In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i2.12
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2015
    detail.hit.zdb_id: 2738279-5
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  • 15
    Online Resource
    Online Resource
    Regulatory requirements for Drug master file in context to Canada and Australia
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 6, No. 2 ( 2018-06-15), p. 41-47
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 6, No. 2 ( 2018-06-15), p. 41-47
    Abstract: Drug Master Files are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug’s identity, strength, purity and quality. Canada and Australia which are consider as highly regulated markets (HRMs). In CANADA, DMF filing was done through New Drug Submission (NDS) for both drugs and biologic products. They use MF terminology for DMF which contain four types of MASTER FILE- ASMFs, CCS MFs, Excipient MFs, Drug product MFs. In AUSTRALIA different application processes and regulatory requirements apply depending on the type of therapeutic goods that is applied. They consist of eight phase for DMF registration. Where EU guidelines adopted in Australia include references to EU legislation. Now from 2016 onwards most of the regulated countries will use eCTD or their electronic format for their DMF submission. Compare DMF regulatory requirements in the above-mentioned countries so that reader can have clear idea on how to file DMF.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v6i2.236
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
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  • 16
    Online Resource
    Online Resource
    COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 3 ( 2018-02-13), p. 8-20
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 3 ( 2018-02-13), p. 8-20
    Abstract: To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a beneficial approach for getting approval of Abbreviated New Drug Application (ANDA) while, BCS based Biowaiver is the novel approach to gain approval for New Drug Application (NDA) as well as ANDA. A Biopharmaceutics Classification System (BCS) based Biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. The Paper covers different kind of Biowaiver approaches and the criteria for the applicability of BCS based Biowaivers in the different geographic scopes with regard to global development strategy. There is a comparison of global guidelines on provisions availability for different types of Biowaiver approaches as well as for requirements of Biowaiver based on BCS. From comparison of different global guidelines it is reviewed that most of the guidance resembles to the USFDA, EU and WHO guidelines because most of the regulatory authorities are following the BCS based Biowaiver concept as one of the three main guidance documents (USFDA, EMA, WHO) or a combination of specific requirements.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i3.167
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 17
    Online Resource
    Online Resource
    COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 1 ( 2018-02-13), p. 75-87
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 1 ( 2018-02-13), p. 75-87
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i1.159
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 18
    Online Resource
    Online Resource
    PROBIOTIC FUNCTIONAL FOOD VS DRUGS: IMPACT OF INDIAN REGULATORY STATUS ON DESIGN OF QUALITY CONTROL GUIDLINES FOR PROBIOTICS
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 3 ( 2018-02-13), p. 28-35
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 3 ( 2018-02-13), p. 28-35
    Abstract: Probiotic now a day's  generally utilized all around the globe because of headway as a part of the relationship in the middle of nourishment and wellbeing other than their promising helpful advantages and irrelevant reactions. Indian probiotic industry is accomplishing its pace at relentless rate with open doors for fast development in not so distant future. Indian probiotic business sector is esteemed at US $310 million in 2011, is required to witness US $522.8 million by 2018. Presentation of a scope of pharmaceutical probiotic definitions in the business sector further expanded the turnover of probiotic industry. The eventual fate of probiotic sustenance's is notwithstanding encouraging, as current buyers are concerned to keep up their own wellbeing, and expect the nourishment that they eat to be solid and equipped for counteracting ailment. this is the time when Indian regulatory bodies/ authorities should prepare a guideline to evaluate efficacy claims rigorously, and by consumers interested in potential therapeutic and preventive health benefits. The Indian marketplace is a mixed bag of products, some well-defined and properly evaluated in controlled clinical studies and others with unsubstantiated claims of efficacy. Validation of probiotic contents in commercial products is needed to ensure consumer confidence. Probiotics must be identified to the level of strain, must be characterized for the specific health target, and must be formulated into products using strains and doses shown to be efficacious. Several characteristics commonly presumed to be essential to Probiotics, such as human origin and the ability to improve the balance of the intestinal microbiota, are discussed.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i3.169
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 19
    Online Resource
    Online Resource
    Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 2 ( 2019-06-16), p. 51-61
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 2 ( 2019-06-16), p. 51-61
    Abstract: To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. This agreed upon common format in the form of CTD format and ACTD format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will be more ease to submit the file having electronic database.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v7i2.318
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2019
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 20
    Online Resource
    Online Resource
    REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 1 ( 2018-02-13), p. 62-74
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 1 ( 2018-02-13), p. 62-74
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i1.158
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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