Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
The document filing for a pharmaceutical product is done in the form of dossier. The slides explain the format and content to be included in all the formats of dossiers.
Carlos Langezaal - Eisai Inc, Speaker at the marcus evans Discovery Summit Fall 2011, delivers his presentation on The Importance of Developing a Global Regulatory Strategy towards the Goal of Registration
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
The document filing for a pharmaceutical product is done in the form of dossier. The slides explain the format and content to be included in all the formats of dossiers.
Carlos Langezaal - Eisai Inc, Speaker at the marcus evans Discovery Summit Fall 2011, delivers his presentation on The Importance of Developing a Global Regulatory Strategy towards the Goal of Registration
Overcoming the stress of non-prescription medicine application screening - Co...TGA Australia
This presentation will describe how the TGA undertakes the screening process and will discuss the mandatory requirements for applications, including specific examples of problems commonly encountered.
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Regulatory aspect of pharamacutical packgingvineet gupta
There is no doubt that the regulatory climate is getting more restrictive for pharmaceutical products and it is likely that packaging for pharmaceuticals will have more and more constraints placed upon it.
20. Efficacy (Clinical Documentation) Deficiency letter to applicant / oral discussion if necessary Applicant‘s Response Document Phase 2 = Evaluation of the response document Quality, Toxicology-Pharmacology, Clinic Decision on the application National Procedure National committee/board Marketing Authorization Pre-submission meeting for the MRP ‚ Scientific Advice‘ Pre-submission meeting
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32. Pre-submission Phase 1 Clock Stop Phase 2 Opinion Decision Post Authorization Day 0• -----------------Start of procedure Day 80--------------- -Rapporteur/Co-Rapporteur’s Assessment Reports Day 100--------------- Comments of CHMP member States / experts Day 120----------------Adoption of the consolidated List of Questions) (Q, S, E, SPC, Labelling, PIL)
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41. Applicant submits dossier Validation Concerned Member States Day 0 - 50 - Evaluation of assessment report and experts reports (and dossier) - Quality (Chemical, Pharmaceutical and Biological Documentation) - Safety ( Toxicological-Pharmacological Documentation) - Efficacy (Clinical Documentation) -Comments/Objections to Reference Member State and Applicant Applicants Response Document Evaluation of the response document Day 75 Break out session /discussion Day 90 Decision on the application EU-MSs National authorities/agencies Marketing authorization Applicant submits national texts
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