Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD &amp; CTD format

Godiyal, Shrikant

doi:10.22270/ijdra.v7i2.318

Cited by 4 publications

(6 citation statements)

References 2 publications

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“…In Indonesia, it is required to submit the dossier in a floppy disc and the receipt of payment for the scrutiny. 11 The registration-dossier requirements for drug products and active ingredients should be provided in Electronic Information Standard format (STENIL-Standard Informasi Elecktronic) written in floppy discs. The provided data must be made in the different forms, Form A, Form B21, Form B13, Form B4, Form C1 and Form D. 12 In Malaysia, the regulatory submission of the dossier has to be made only online via www.bpfk.gov.my as recommended by DCA.…”

Section: Discussionmentioning

confidence: 99%

Generic Drugs Regulations and Registration in Indonesia, Malaysia and Vietnam: A Drug Regulatory Case Study

DS¹,

CR²,

Vadakkepushpakath³

et al. 2022

JYP

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Generic drug regulations and registration process in IndonesiaIndonesia has a population of about 272.25 million. The drug regulatory authority in Indonesia is the National Agency of Drugs and Food Control (NA-DFC), located in Jakarta, the capital of Indonesia. For the submission of generic drugs to be approved, the ACTD format is followed in Indonesia. 7 The generic drug registration and approval process in Indonesia is described in Figure 2.

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Section: Discussionmentioning

confidence: 99%

Generic Drugs Regulations and Registration in Indonesia, Malaysia and Vietnam: A Drug Regulatory Case Study

DS¹,

CR²,

Vadakkepushpakath³

et al. 2022

JYP

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“…Their recommendation at all stages, both as far as lawful and specialized prerequisites, help organizations with saving a ton of time and cash in fostering the item and promoting something analogous. For nations that don't have their own guidelines the World Health Organization rules on wellbeing matters and World Trade Organization on exchange guidelines between countries are observed [14][15][16].…”

Section: Regulatory Affairs In Product Managementmentioning

confidence: 99%

“…At its center, the RA proficient works with the assortment, examination and correspondence about the dangers and advantages of wellbeing items to the Regulatory organizations, clinical and wellbeing frameworks and people in general. Functionally RA is answerable for guaranteeing that administration commitment, market driven requests and developing logical shows are perceived and tended to by different partners [14][15][16].…”

Section: Regulatory Affairs In Clinical Trialsmentioning

confidence: 99%

“…With new items expected to add critical incomes to the organization's primary concerns, little abatement to advertise compare to enormous material additions in income and benefit. Utilizing versatile clinical preliminary methodologies, acquiring fast endorsement from Regulatory specialists and staying away from traps in cycles can speed up advancement of new items and assist with lessening exorbitant blunders and delays [14][15][16].…”

Section: Regulatory Affairs In R and Dmentioning

confidence: 99%

“…They are expected to be knowledgeable in the regulations, guidelines, rules and direction of the Regulatory organizations. There is a developing need to consolidate the ongoing prerequisites of drug ventures in the standard educational program of drugstore schools to set up the understudies with the furthest down the line improvements to serve the businesses" [14][15][16].…”

Section: Need Of Regulatory Affairs In the Medical Device Curri-culummentioning

confidence: 99%

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Role of Regulatory Affairs in a Medical Device Industry

Sharma¹,

Luthra²

2022

CJAST

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Regulatory Affairs experts are the important part of the Medical Device industry since it is concern about the orthopaedic Implant/Instruments lifecycle, it gives key, strategic and functional bearing and backing for working inside guidelines to speed up the turn of events and conveyance of protected and compelling orthopaedic products to people all over the globe. The responsibility of regulatory affairs is to create and execute an regulatory system to guarantee that the medical device product is approvable by worldwide different regulatory authorities, but on the other hand is separated from the opposition somehow or another and furthermore is to guarantee that the organization's exercises, from non-clinical exploration through to publicizing and advancement, are lead as per the guidelines and rules laid out by Regulatory Authorities. Regulatory Affairs is an appealing profession decision for graduate understudies from a logical foundation who appreciate correspondence and cooperation, are compatible with performing various tasks and are anxious to grow their insight in the wide domains of the Medical world. Regulatory Affairs is a fulfilling, mentally invigorating and exceptionally respected department inside Medical device companies. In this research article different regulatory authorities worldwide are taken into the contrast for medical devices approvals and regulatory controls. The role and importance of the regulatory affairs professional is pictured as a bridge between the medical device industry and different regulatory authorities worldwide.

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Streamlining Regulatory Documentation: Exploring the Common Technical Document (Ctd) and Electronic Submission, With Emphasis on M Series According to Ich Guidelines

RASHYAP SARASWAT,

ANKITA RAIKWAR,

SUBHRANSHU PANDA

2024

Asian J Pharm Clin Res

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A number of regulatory bodies have worked together to create the Common Technical Document (CTD), including the United States Food and Drug Administration, the European Medicines Agency, and the Japanese Ministry of Health. This standardized format facilitates the collection and submission of regulatory documentation pertaining to applications for new medicines. Since its inception in 2000, the CTD has been widely adopted internationally, including by nations such as Canada, Australia, and India. The CTD aims to streamline the submission process, reduce duplication of effort, and facilitate regulatory evaluations by providing a uniform structure for technical documentation. This article outlines the guidelines and organization of the CTD, including its modules covering administrative information, quality, non-clinical studies, and clinical trials. The CTD’s significance lies in its ability to improve regulatory efficiency, promote data transparency, and expedite the availability of new medicines to patients. However, challenges persist, such as variations in regional requirements and the need for continued adaptation to evolving technological standards. Electronic submissions and improved information management are two ways in which the new electronic CTD (eCTD) has improved submission procedures. Despite some ongoing issues, the CTD and eCTD represent significant advancements in regulatory documentation, with the potential for further innovation and global adoption in the future.

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Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format

Cited by 4 publications

References 2 publications

Generic Drugs Regulations and Registration in Indonesia, Malaysia and Vietnam: A Drug Regulatory Case Study

Generic Drugs Regulations and Registration in Indonesia, Malaysia and Vietnam: A Drug Regulatory Case Study

Role of Regulatory Affairs in a Medical Device Industry

Streamlining Regulatory Documentation: Exploring the Common Technical Document (Ctd) and Electronic Submission, With Emphasis on M Series According to Ich Guidelines

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