Academic literature on the topic 'Dossier Preparation'

The Russian Federation and the member states of the Eurasian Economic Union (EAEU) are working on the creation of a common pharmaceutical market. EAEU marketing authorisation may be granted to those pharmaceutical companies whose activities comply with the Good Pharmacovigilance Practice (GVP). The aim of the study was to analyse pharmacovigilance system documents submitted as part of registration dossiers of medicines and to identify problems that may arise during preparation of the pharmacovigilance system master file (PSMF). The authors analysed the PSMF, which makes part of the registration dossier, for compliance with the EAEU GVP requirements for submission, content, and completeness of all sections of the document. They identified the most common types of errors in PSMF preparation and analysed conditions when a PSMF is required or, alternatively, when a brief summary of the pharmacovigilance system of the marketing authorisation holder will suffice. The paper summarises specific aspects of incorporating pharmacovigilance system documents in regulatory submissions, as well as aspects of presenting pharmacovigilance system data when bringing the registration dossier in line with the EAEU requirements. This information may be useful for marketing authorisation holders who are the main stakeholders in the medicine authorisation process and who are directly involved in the pharmacovigilance system management during the authorisation and post-authorisation stages of the drug life-cycle.

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.

PurposeThe internationalization of pharmaceutical firms faces major barriers in terms of managing regulatory requirements in various international markets. This paper aims to identify the requirements related to regulations in various markets of the world. It further seeks to identify how the firms develop such capabilities i.e. processes undertaken by the firms to develop regulatory capabilities.Design/methodology/approachThe research is exploratory in nature. Case study method is adopted to study the requirements related to regulations in international markets and processes to build regulatory capabilities.FindingsTo manage regulatory requirements firms need knowledge related to plant approval and product registration. Firms have to submit dossiers to the respective country's regulatory authority to get plant approval and product registration. They can simultaneously apply for both to save time to enter the target market. The requirements for each market are unique in terms of format and contents for dossier preparation. Dossier preparation needs data from various departments which calls for good coordination among various functional areas, i.e. production, QA and QC, R&D, purchasing, etc. If the firm has operations in multiple markets and offers multiple products in a single market the regulatory function is separately organized for less regulated, semi‐regulated and regulated markets.Practical implicationsPharmaceutical firms targeting international markets can get insight into the regulatory requirements and the process to be adopted to build regulatory requirements.Originality/valueThe paper shows that firms use a systematic process to build capabilities for managing regulations. The paper also offers a process model for firms to build regulatory capabilities for internationalization.

ACTD is a critical document for drug substance and produces registration in ASEAN region. The document is essentially divided into 4 parts. Each part provides information under specific head. Out of all the parts, the part II is most important. This part not only evaluates technical suitability of the product but also determines the suitability of active drug and Excipients.
 The major stress in this part is on formulation, manufacturing, stability and process validation. The information required under this part is suitably detailed in this article.

The Medicines Control Authority of Zimbabwe (MCAZ) is the authority to regulate from the Ministry of Health. It is established through an Act of Parliament which gives these bodies the `power to regulate the quality and sale of Complementary medicines. The objectives of this study were to evaluate the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate overall performance from 2017 to 2019, identify best practices in review, evaluate the quality of decision-making processes and identify challenges and opportunities for improvement. Complementary medicine has always been at the heart of most Zimbabweans. That most of the drug is located close to the African community makes it very attractive, user-friendly, cost-effective and flexible in adapting to the dynamics of modern societal trends. The aim is to understand the need for professionalization of complementary medicine. The guidelines were studied from the website. We studied the guidelines to prepare a checklist and dossier preparation to submit to the authority of Zimbabwe.

The main purpose of this article is to research the requirement of the veterinary drug dossier submission in the three countries is US, EU, and Canada and the procedure of all the three countries are different for the submission of the veterinary drug dossier and their rules and regulation are different but all the three countries follow the VICH guidelines in these articles all the information available like necessary documents timeline approval procedure are different for US, EU, and Canada.

The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. The attitudes and actions of Regulatory Affairs Professionals will condition the perceptions of the government officials to the company. Dossier is a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. This guideline merely demonstrates an appropriate write-up format for acquired data. Throughout the ACTD, the display of information should be unambiguous and transparent, in order to facilitate the review of the basic data and to help a reviewer become quickly oriented to the application contents. This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. ICH‐ECTD is an internationally driven standard designed to reduce cost in the administration, assessment and archiving of applications for marketing authorization of medicinal products for human use, to reduce the use of paper and streamline the assessment process making the system more efficient.

AbstractThis article examines how dossier files informed the handling of personnel misconduct in Chinese work units using an investigation of adultery as a case study. By the Cultural Revolution (1966–1976), the disciplinary functions of the dossier system were an embedded feature of social control in the work unit, partially shifting responsibility for policing petty crime to local administrators. In this case, the revelation of an extramarital relationship in 1974 set off a bureaucratic operation to produce documentary proof of the alleged wrongdoing. The thick case file prepared by the work unit investigators grew to include a tranche of seized love letters, a series of dubious confessions, and detailed bureaucratic reports. The preparation of evidence bound for the dossier demonstrates the extent to which the demands of documentation formed a distinct end of the investigative process, while revealing how people and paper were mobilized to deal with a minor administrative affair.

<em>Common Technical Document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant differences in the dossier submission requirements in these countries. This study put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authorization of the generic medicinal product in Europe, the applicant should submit abridged application to the relevant authority. The ability to accommodate country specific requirements and understand regulatory differences will have a substantial impact on the success of its multi country submissions strategy. Generic manufacturers must file an Abbreviated New Drug Submission (ANDS), and the CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approval procedures.</em> <strong>Keywords:</strong><em> CTD, Generic drug, CDSCO, Bioequivalence, ANDS.</em>

Magister Pharmaceuticae - Mpharm<br>The aim of this study was to determine quality control specifications needed for a dossier and an investigator's brochure of A. afra capsules, which can be used to motivate the registration and clinical testing of A. afra capsules in chronic asthma. The specific objectives were: (1) to establish the minimum product quality requirements for registration of A. afra capsules, (2) to prepare and pharmaceutically characterize a capsule product of A. afra freeze dried aqueous extract (FDAE) suitable for registration, and (3) to identify pharmaceutical product quality aspects of an investigator's brochure (IB) that would be appropriate for use in motivating a clinical trial of A. afra capsules in chronic asthma.

La première partie de l’étude est consacrée à l’invocation, intra et extra muros, du droit à un procès équitable. Sont analysés ainsi, dans un premier temps, l’applicabilité directe de l’article 6 et la subsidiarité de la Convention par rapport au droit national et de la Cour Européenne des Droits de l’Homme par rapport aux juridictions nationales. Le droit à un procès équitable étant un droit jurisprudentiel, l’étude se focalise, dans un second temps, sur l’invocabilité des arrêts de la Cour Européenne et plus précisément sur l’invocabilité directe de l’arrêt qui constate une violation du droit à un procès équitable dans une affaire mettant en cause l’Etat et l’invocabilité de l’interprétation conforme à l’arrêt qui interprète l’article 6 dans une affaire mettant en cause un Etat tiers. L’introduction dans l’ordre juridique français et hellénique de la possibilité de réexamen de la décision pénale définitive rendue en violation de la Convention a fait naitre un nouveau droit d’accès à la Cour de cassation lequel trouve son terrain de prédilection aux violations de l’article 6 et constitue peut-être le pas le plus important pour le respect du droit à un procès équitable après l’acceptation (par la France et la Grèce) du droit de recours individuel. Quant au faible fondement de l’autorité de la chose interprétée par la Cour Européenne, qui est d’ailleurs un concept d’origine communautaire, cela explique pourquoi un dialogue indirect entre la Cour Européenne et la Cour de cassation est possible sans pour autant changer en rien l’invocabilité de l’interprétation conforme et le fait que l’existence d’un précédent oblige la Cour de cassation à motiver l’interprétation divergente qu’elle a adoptée.La seconde partie de l’étude, qui est plus volumineuse, est consacrée aux garanties de bonne administration de la justice (article 6§1), à la présomption d’innocence (article 6§2), aux droits qui trouvent leur fondement conventionnel dans l’article 6§1 mais leur fondement logique dans la présomption d’innocence et aux droits de la défense (article 6§3). Sont ainsi analysés le droit à un tribunal indépendant, impartial et établi par la loi, le délai raisonnable, le principe de l’égalité des armes, le droit à une procédure contradictoire, le droit de la défense d’avoir la parole en dernier, la publicité de l’audience et du prononcé des jugements et arrêts, l’obligation de motivation des décisions, la présomption d’innocence, dans sa dimension procédurale et personnelle, le « droit au mensonge », le droit de l’accusé de se taire et de ne pas contribuer à son auto-incrimination, son droit d’être informé de la nature et de la cause de l’accusation et de la requalification envisagée des faits, son droit au temps et aux facilités nécessaires à la préparation de la défense, y compris notamment la confidentialité de ses communications avec son avocat et le droit d’accès au dossier, son droit de comparaître en personne au procès, le droit de la défense avec ou sans l’assistance d’un avocat, le droit de l’accusé d’être représenté en son absence par son avocat, le droit à l’assistance gratuite d’un avocat lorsque la situation économique de l’accusé ne permet pas le recours à l’assistance d’un avocat mais les intérêts de la justice l’exigent, le droit d’interroger ou faire interroger les témoins à charge et d’obtenir la convocation et l’interrogation des témoins à décharge dans les mêmes conditions que les témoins à charge et le droit à l’interprétation et à la traduction des pièces essentielles du dossier. L’analyse est basée sur la jurisprudence strasbourgeoise et centrée sur la position qu’adoptent la Cour de cassation française et l’Aréopage<br>The first party of the study is dedicated to the invocation of the right to a fair trial intra and extra muros and, on this basis, it focuses on the direct applicability of Article 6 and the subsidiarity of the Convention and of the European Court of Human Rights. Because of the fact that the right to a fair trial is a ‘‘judge-made law’’, the study also focuses on the invocability of the judgments of the European Court and more precisely on the direct invocability of the European Court’s judgment finding that there has been a violation of the Convention and on the request for an interpretation in accordance with the European Court’s decisions. The possibility of reviewing the criminal judgment made in violation of the Convention has generated a new right of access to the Court of cassation which particularly concerns the violations of the right to a fair trial and is probably the most important step for the respect of the right to a fair trial after enabling the right of individual petition. As for the weak conventional basis of the authority of res interpretata (“autorité de la chose interprétée”), this fact explains why an indirect dialogue between the ECHR and the Court of cassation is possible but doesn’t affect the applicant’s right to request an interpretation in accordance with the Court’s decisions and the duty of the Court of cassation to explain why it has decided to depart from the (non-binding) precedent.The second party of the study is bigger than the first one and is dedicated to the guarantees of the proper administration of justice (Article 6§1), the presumption of innocence (Article 6§2), the rights which find their conventional basis on the Article 6§1 but their logical explanation to the presumption of innocence and the rights of defence (Article 6§3). More precisely, the second party of the study is analyzing the right to an independent and impartial tribunal established by law, the right to a hearing within a reasonable time, the principle of equality of arms, the right to adversarial proceedings, the right of the defence to the last word, the right to a public hearing and a public pronouncement of the judgement, the judge’s duty to state the reasons for his decision, the presumption of innocence, in both its procedural and personal dimensions, the accused’s right to lie, his right to remain silent, his right against self-incrimination, his right to be informed of the nature and the cause of the accusation and the potential re-characterisation of the facts, his right to have adequate time and facilities for the preparation of the defence, including in particular the access to the case-file and the free and confidential communication with his lawyer, his right to appear in person at the trial, his right to defend either in person or through legal assistance, his right to be represented by his counsel, his right to free legal aid if he hasn’t sufficient means to pay for legal assistance but the interests of justice so require, his right to examine or have examined witnesses against him and to obtain the attendance and examination of witnesses on his behalf under the same conditions as witnesses against him and his right to the free assistance of an interpreter and to the translation of the key documents. The analysis is based on the decisions of the European Court of Human Rights and focuses on the position taken by the French and the Greek Court of Cassation (Areopagus) on each one of the above mentioned rights

Considerations and requirements for taking an oligonucleotide therapeutic, synthesized with innovative sustainable processes, from the laboratory to clinical trials are discussed considering the regulatory aspects related to impurities and to the preparation of dossiers.

Abstract In order to ensure the proper efficiency of an offshore LNG project, it is essential to maintain the safe and continuous operations and to reduce the downtime due to the maintenance activities. In this purpose, GTT has developed an innovative digital solution, the SVS, to monitor the sloshing activity inside the LNG tanks in operation and allowing to extend the cargo tank entry period while complying with the requirements of the regulatory authorities. The purpose of the paper is to share the background and the learnings of this world's first ever preparation and implementation of Alternative Survey Plan supported by Sloshing Virtual Sensor solution as well as the other engineering work related to the cargo tanks for this FSU conversion project. It will include the different steps, from the HAZID workshop with all stakeholders following a RBI approach to the performance of the engineering justification dossier and deployment of the digital solution onboard the FSU.

The Planning Act of 28 June 2006 prescribed that a reversible repository in a deep geological formation be chosen as the reference solution for the long-term management of high-level and intermediate-level long-lived radioactive waste. It also entrusted the responsibility of further studies and investigations on the siting and design of the new repository upon the French Radioactive Waste Management Agency (Agence nationale pour la gestion des de´chets radioactifs – Andra), in order for the review of the creation-licence application to start in 2015 and, subject to its approval, the commissioning of the new repository in 2025. In late 2009, Andra submitted to the French government proposals concerning the implementation and the design of Cige´o (Centre industriel de stockage ge´ologique). A significant step of the project was completed with the delineation of an interest zone for the construction of the repositor’s underground facilities in 2010. This year, Andra has launched a new dialogue phase with local actors in order to clarify the implementation scenarios on the surface. The selected site will be validated after the public debate that is now scheduled for the first half of 2013. This debate will be organized by the National Public Debate Committee (Commission nationale du de´bat public). In parallel, the State is leading the preparation of an territorial development scheme, which will be presented during the public debate. The 2009 milestone also constitutes a new step in the progressive design process of the repository. After the 1998, 2001 and 2005 iterations, which focused mainly on the long-term safety of the repository, the Dossier 2009 highlighted its operational safety, with due account of the non-typical characteristics of an underground nuclear facility. It incorporates the first results of the repository-optimisation studies, which started in 2006 and will continue in the future. The reversibility options for the repository constitute proposals in terms of added flexibility in repository management and in package-recovery levels. They orient the design of the repository in order to promote those reversibility components. They contribute to the dialogue with stakeholders in the preparation of the public debate and of the future act on the reversibility conditions of the repository. The development of the repository shall be achieved over a long period, around the century. Hence, the designer will acquire additional knowledge at every new development of the project, notably during Phase 1, which he may reuse during the following phase, in order, for instance, to optimise the project. This process is part of the approach proposed by Andra in 2009 pursuant to the reversibility principle.

INTRODUCTION Treatment options for the highly neglected fungal tropical disease eumycetoma are limited and poorly adapted to patients’ contexts, with surgery often required. The first-line treatment, itraconazole, thought to be 40% effective, must be taken twice daily for ≥12 months with food, making adherence difficult. An effective, affordable, context-appropriate treatment is urgently needed. The Drugs for Neglected Diseases Initiative (DNDi) repurposed the broad-spectrum antifungal agent fosravuconazole, developed by Eisai Ltd for onychomycosis. We aimed to compare two different doses of weekly fosravuconazole with standard-of-care daily itraconazole in patients with eumycetoma. METHODS This phase 2, randomised, double-blind, active-controlled, superiority trial was done at the Mycetoma Research Centre, Soba University Hospital, Sudan. Patients aged ≥15 years with a small-to-medium lesion (≥2 to &lt;16 cm) caused by M mycetomatis requiring surgery were randomly assigned (1:1:1) to receive either 300 mg fosravuconazole weekly (group 1), 200 mg fosravuconazole weekly (group 2), or 400 mg itraconazole daily (group 3), for 12 months, together with surgery at 6 months in all groups. The primary efficacy endpoint, assessed in all patients receiving at least one dose of study drug (modified intention to treat), was complete cure at 12 months (absence of eumycetoma mass and sinuses and discharge with normal imaging; or a negative fungal culture if mass present). Safety was assessed in patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov (NCT03086226). RESULTS Between 9 May, 2017, and 10 June, 2021, 104 patients were randomised (34 to group 1, 34 to group 2, and 36 to group 3).Median age was 29.0 (IQR22.0–33.0), 23.0 (20.0–29.0) and 24.5 (19.5–33.0) years for Groups 1, 2, and 3 respectively. Complete cure rates at end of treatment were 50.0% (95% CI 32.4–67.6), 64.7% (46.5–80.3), and 75.0% (57.8–87.9) with Groups 1, 2 and 3, respectively, showing no superiority of fosravuconazole over the standard-of-care (p=0.030 for Group 2 vs Group 3; and p=0.347 for Group 1 vs Group 3; with significance level set at 0.022). Treatment-emergent adverse drug reactions were reported in one (3%) of 34 patients in group 2 (nausea or vomiting) and three (8%) of 36 patients in group 3 (cortisol decreased, QT prolonged). CONCLUSION Although not superior, fosravuconazole 200 mg seemed to have similar efficacy to itraconazole, coupled with advantages such as a weekly, not daily, administration, no food effect, and low risk for drug-drug interactions. An early access programme is under review by authorities in Sudan and a regulatory dossier and global access plan are under preparation.