Post approval regulatory affairs pdf

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What Should I Include In An Application? How Will My Application Be Processed? How Do I Make Changes To An Authorisation? Data for the chemistry of the formulation and toxicology? Under what legislation will applications be considered? Guidance on how to use these products safely and information about controls over pesticide residues in food.

HSE aims to reduce work-related death, injury and ill health. In this post, the below listed eCTD aspects will be discussed in detail, as they are important for avoiding eCTD related deficiencies. The file name is to be given in abbreviated form with the use of small letters. The title is generally not given under document properties.

Irrespective of the version of Adobe Acrobat, PDF Version should be anything from 1. For Submissions to USFDA, Pages size should be 8. 5 and there are no bookmarks. The maximum length of the filename should be 64 characters. The leaf element path length should not exceed 230 characters.

Times New Roman 12-point font, is recommended and should be preferred for narrative text. Point Size 10 is recommended for footnotes. PDF viewing software, substitutes non-standard fonts if the font used to create the text is unavailable on the reviewer’s computer. In some cases, substitution of standard fonts like Helvetica or Times is done by PDF viewing software. Font substitution can affect a document’s appearance and structure, and in some cases it can affect the information conveyed by a document. Hence, embedding of fonts should be ensured.

However, embedding of font should be avoided for labels and electronically signed documents. The table with list of standard fonts are provided below. You could Google it and follow. If you are facing any difficulty, I’ll be happy to help out. There should be appropriate number of bookmarks in the document. The number of bookmarks should be neither less nor more.

The number of sub heading trees within book marks should be limited to 3 or 4. Hyper linking of texts to the destination is to be ensured, wherever applicable. It commonly happens that, clarity of documents is not checked before submitting to the Agency. If we are not able to read a document due to lack of clarity, we definitely cannot expect the reviewer to read the document. The probability of Plant Layouts lacking clarity is more. Hence, clearly scanned Plant Layouts should be submitted.

The above post could also be considered for NDA submissions. I have listed the most important aspects which are to be considered to avoid eCTD Deficiencies. Please refer the below references for complete information related to eCTD. January,  2012, amended the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars and for other purposes. What is GDUFA and why was it implemented by FDA?

GDUFA was implemented to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. Under GDUFA, certain facilities, sites, and organizations must self-identify and may be Subject to user fees. GDUFA requires industry to pay user fees, which will supplement the costs of reviewing generic drug applications and inspecting facilities. The money earned by FDA through GDUFA will help FDA to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk- based inspections. Over the past 20 years, PDUFA has ensured a more predictable, consistent, and streamlined premarket program for industry and helped speed access to new, safe and effective prescription drugs for patients. GDUFA will also enhance global supply chain safety by requiring that generic drug facilities and sites around the world self-identify.