The document discusses different formats for submitting a dossier to regulatory agencies for approval of new pharmaceutical products. It describes Common Technical Document (CTD) format as the most commonly accepted one, consisting of five modules. Electronic CTD (eCTD) is the electronic version of CTD in PDF format arranged hierarchically. ASEAN Common Technical Dossier (ACTD) is a similar format accepted in Southeast Asian countries, consisting of four parts providing administrative, quality, non-clinical, and clinical information. Non-electronic CTD (NeeS) differs in that it does not contain the underlying XML structure and must have bookmarks and hyperlinks for navigation.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
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.
Abbreviated New Drug Application (ANDA) Submission:
Introduction
Basic Generic Drug Requirements
Goals of ANDA
Basis of ANDA Submission
ANDA Forms and Submission Requirements
ANDA Review Process
CTD Triangle
Electronic Submissions
Checklist for ANDA submission (Module 1 to Module 5)
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
This presentation gives an overview of the Drug Master File, a document submitted by the company or pharmaceutical industry to the regulatory authorities. It indicates that the company's product meets the desired quality standards. A brief introduction followed by types of DMF, its reviewing procedure and applications may give you a better understanding about Drug Master File.
Scale up and post approval changes guidelines for IR, MR and Non SS dosage form helps to changes in the composition, batch size , site of manufacturing and equipment and manufacturing process after the approval at large scale
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
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.
Abbreviated New Drug Application (ANDA) Submission:
Introduction
Basic Generic Drug Requirements
Goals of ANDA
Basis of ANDA Submission
ANDA Forms and Submission Requirements
ANDA Review Process
CTD Triangle
Electronic Submissions
Checklist for ANDA submission (Module 1 to Module 5)
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
This presentation gives an overview of the Drug Master File, a document submitted by the company or pharmaceutical industry to the regulatory authorities. It indicates that the company's product meets the desired quality standards. A brief introduction followed by types of DMF, its reviewing procedure and applications may give you a better understanding about Drug Master File.
Scale up and post approval changes guidelines for IR, MR and Non SS dosage form helps to changes in the composition, batch size , site of manufacturing and equipment and manufacturing process after the approval at large scale
REGISTRATION OF INDIAN DRUG PRODUCT IN OVERSEAS MARKET.pptxMurthujavali Miper
The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.
Since there are many formats of dossier filing, these slides explain in detail about the particular format followed in South East Asian Countries, i.e., ACTD
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
Nicely described regarding about the overview of ICH guidelines as per PCI syllabus specially for Pharmacy students not only for pharmacy student for all. It include Quality, Safety, Efficacy & Multidisciplinary guidelines and also include Common Technical Document & Electronic Common Technical Document.
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
বাংলাদেশের অর্থনৈতিক সমীক্ষা ২০২৪ [Bangladesh Economic Review 2024 Bangla.pdf] কম্পিউটার , ট্যাব ও স্মার্ট ফোন ভার্সন সহ সম্পূর্ণ বাংলা ই-বুক বা pdf বই " সুচিপত্র ...বুকমার্ক মেনু 🔖 ও হাইপার লিংক মেনু 📝👆 যুক্ত ..
আমাদের সবার জন্য খুব খুব গুরুত্বপূর্ণ একটি বই ..বিসিএস, ব্যাংক, ইউনিভার্সিটি ভর্তি ও যে কোন প্রতিযোগিতা মূলক পরীক্ষার জন্য এর খুব ইম্পরট্যান্ট একটি বিষয় ...তাছাড়া বাংলাদেশের সাম্প্রতিক যে কোন ডাটা বা তথ্য এই বইতে পাবেন ...
তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
বিসিএস ও ব্যাংক এর লিখিত পরীক্ষা ...+এছাড়া মাধ্যমিক ও উচ্চমাধ্যমিকের স্টুডেন্টদের জন্য অনেক কাজে আসবে ...
Delivering Micro-Credentials in Technical and Vocational Education and TrainingAG2 Design
Explore how micro-credentials are transforming Technical and Vocational Education and Training (TVET) with this comprehensive slide deck. Discover what micro-credentials are, their importance in TVET, the advantages they offer, and the insights from industry experts. Additionally, learn about the top software applications available for creating and managing micro-credentials. This presentation also includes valuable resources and a discussion on the future of these specialised certifications.
For more detailed information on delivering micro-credentials in TVET, visit this https://tvettrainer.com/delivering-micro-credentials-in-tvet/
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
2. Table of Contents
• Dossier
• Goals of Dossier Filing
• Contents of Dossier
• Format of Dossier
• CTD
• eCTD
• ACTD
• NeeS
3. Dossier
Dossier is a collection or file of documents on some subject, especially
a file containing detailed information about a person or a topic.
Dossiers are the vehicle in a country through which drug sponsors
formally propose that the regulatory agencies approve a new
pharmaceutical product.
In pharmaceutical field, Dossier can be defined as a technical
document on a pharmaceutical product for human use that has to go
through the reviewing and assessment.
4. Goals of Dossier filing
A dossier enables the regulatory agencies t review and evaluate every
minor information abut the proposed pharmaceutical product, to seek
answers for the following questions:
• Is the drug safe and effective in its proposed use, when used as
directed?
• Do the benefits of the product outweigh the risks associated?
• Is the drug product’s labelling appropriate?
5. • Are the methods used in manufacturing the drug maintain the quality,
strength and purity od the product?
• What does the drug product contains (i.e., ingredients)?
In short, the key goal of the dossier filing is to ensure the quality, safety
and efficacy of the drug product
6. Contents of Dossier
• Data providing that the drug has quality, efficacy, and safety
properties suitable for the intended use.
• Any additional administrative documents (SMF, DMF, PDP, MFR, BMR,
etc.)
• Samples of finished products
• Related substances and reagents necessary to perform analysis of
finished product.
7. Format of Dossier
• Every country has its own rules and regulations for the submission and
format of dossier. Hence, it is mandatory to possess the knowledge about
exact regulatory requirements of the particular country.
• Because the submission of application that does not comply with the
guidelines may result in delays, queries, and rejection.
Formats for dossier submission:
• CTD
• eCTD
• ACTD
8. CTD
A Common Technical Document is the most commonly accepted format of the
dossier.
CTD was officially signed off in November,2000 at the 5th ICH Conference, California.
CTD format is widely accepted in Semi regulated and regulated countries.
CTD is accepted for filing:
• INDs (Investigational New Drugs)
• NDAs (New Drugs Applications)
• ANDAs (Abbreviated New Drug Applications)
• BLAs (Biologicals License Applications)
There are five modules in CTD:
9.
10. eCTD
eCTD is nothing but the electronic form of CTD.
Generally, eCTD can be defined as a standard format of submitting the
application for application to the concerned regulatory agency.
An eCTD consists of individual documents in PDF format which are
arranged in a hierarchical form as per CTD structure.
Just like CTD, eCTD also comprises of five modules and is accepted for
all those purposes that are fulfilled by CTD i.e.,
• NDAs
• INDs
• ANDAs
• BLAs
11.
12. ACTD
ACTD is ASEAN Common Technical Document.
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) application which
was submitted to ASEAN regulatory authorities for the
registration of pharmaceuticals for human use.
ASEAN is a CTD document for South East Asian Countries. A
bunch of 10 countries came together to lay down their own rules
and regulations for dossier submission.
13. ASEAN Countries
A bunch of 10 countries came together to join hands and lay down their own rules and regulations
for dossier submission.
List of 10 ASEAN Countries:
1. Laos
2. Burma (Myanmar)
3. Brunei
4. Cambodia
5. Malaysia
6. Singapore
7. Thailand
8. Phillippines
9. Vietnam
10. Indonesia
14. ACTD Format
The ACTD consists of four parts. These four parts contain all the information
required by the regulatory agencies to be submitted by the applicant.
Part 1: Table of Content, Administrative Data and Product Information:
This part contains all the relevant information regarding the whole ACTD to
provide basis details. A general introduction to the pharmaceutical product,
its class, mode of action, etc.
Part 2: Quality Document:
This part provides the overall summary and the study reports.
15. Part 3: Non-Clinical Document:
Part III provides the non-clinical overview, written summaries and
tabulated summaries. But for ASEAN countries, these study reports
may not be required for Major Variation Products if the original product
is already registered and approved in Reference Countries.
Part 4: Clinical Document:
Part IV provides the Clinical overview and clinical summary. This
document is not needed for generic products.
16.
17. NeeS
NeeS is Non-electronic CTD Submission. NeeS is a n electronic
document generated in PDF format submitted in a CD.
NeeS differs from CTD as it does not contain:
• The XML files that provide the backbone to the CTD format.
NeeS format comprises:
• Table of Contents
• A NeeS format must contain a Table of Content in PDF form
18. • Hyperlinks & Bookmarks:
To locate the content quickly and effectively, hyperlinks and bookmarks
are added to the NeeS. The use of these are recommended:
• To assist the regulatory body to navigate them through the PDF
• Clarity to the document