The document provides an overview of electronic Common Technical Document (eCTD) format for regulatory submissions globally. It defines key terms related to eCTD and describes the history and structure of the Common Technical Document (CTD) format adopted by the International Conference on Harmonization (ICH). The document compares paper, non-eCTD electronic and eCTD submission formats and highlights benefits of eCTD format. It also provides high-level information on eCTD fundamentals, folder structure and backbone XML view. Finally, it discusses key requirements and considerations for electronic submissions to major regulatory authorities in US, EU, Saudi Arabia, GCC countries and Health Canada.
The document provides information for filing an Investigational New Drug (IND) application in electronic Common Technical Document (eCTD) format with the US FDA. It discusses the objectives of filing an IND for the drug Riociguat to treat pulmonary hypertension. It provides background on CTD and eCTD submission formats. It also includes details on the chemistry, manufacturing, and controls of Riociguat, preclinical and clinical studies, labeling, and stability data required for the IND application in eCTD format.
CTD AND ECTD IN QUALITY ASSURANCE BY INTHIYAZ RIPERInthiyazBegum
The document discusses the Common Technical Document (CTD) format and the Electronic Common Technical Document (ECTD) format for submitting documentation to regulatory agencies for drug approval.
The CTD format was agreed upon in 2000 and standardized the organization of documentation into five modules: quality, non-clinical studies, clinical studies, and regional administrative information. The ECTD format further standardized electronic submission in an internationally agreed upon format to facilitate review. Benefits of the CTD and ECTD formats include global harmonization, easier preparation and review of submissions, and reduced costs. Risks of electronic submissions include technical issues and ensuring documentation is properly formatted and validated.
The document discusses the Common Technical Document (CTD) format, which was created by the International Conference on Harmonisation to standardize the submission of documentation for drug approval across regions. It provides a five-module structure for organizing quality, safety, efficacy and other information. While CTD helped streamline submissions, the electronic CTD (eCTD) was later developed to further facilitate electronic transfer and review of documentation between regulators and industry. eCTD utilizes XML formatting and allows lifecycle management of submissions but implementation presents challenges around file formats, regional rules and last minute changes.
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.
The document discusses the Common Technical Document (CTD) format for organizing drug regulatory submissions. It notes that CTD was created to standardize submissions across regions and overcome issues like complex approval processes. CTD structures information into five modules covering administrative data, summaries, quality, nonclinical studies, and clinical studies. The document also describes the electronic CTD (eCTD) format and its benefits like improved submission and review processes through use of standardized electronic files and metadata. Implementation challenges include the need for specialized tools and training as well as varying regional requirements.
The document discusses the Common Technical Document (CTD) and Electronic Common Technical Document (eCTD) formats used for drug registration applications. The CTD format provides a standardized structure for organizing documentation, while the eCTD format digitizes the CTD for electronic submission. Both formats were developed through international harmonization efforts to streamline the drug approval process. The eCTD uses hyperlinks and an XML backbone to improve navigation of application materials compared to the paper-based CTD.
The document provides information on the Common Technical Document (CTD) format for organizing technical documents submitted to regulatory authorities for approval of pharmaceutical products. The CTD format was developed by the International Conference on Harmonization to streamline review processes and facilitate simultaneous submissions across different regions. It includes five modules covering administrative information, summaries, quality, nonclinical and clinical data. Adopting a common format provides benefits like reduced submission time and costs as well as faster availability of new medicines to patients.
The document discusses the Common Technical Document (CTD) and electronic CTD (eCTD) formats for submitting information on medicines to regulatory authorities. The CTD format was introduced in 2000 to harmonize dossier submissions across regions. It organizes information into five modules covering administrative data, quality and safety summaries, nonclinical and clinical study reports. The eCTD is the electronic version that allows electronic submission to improve the review process. Requirements for the eCTD include PDF version, formatting, hyperlinks and file naming conventions. Overall, the CTD and eCTD were created to standardize submissions and facilitate review of medicines by regulatory bodies.
The document provides information for filing an Investigational New Drug (IND) application in electronic Common Technical Document (eCTD) format with the US FDA. It discusses the objectives of filing an IND for the drug Riociguat to treat pulmonary hypertension. It provides background on CTD and eCTD submission formats. It also includes details on the chemistry, manufacturing, and controls of Riociguat, preclinical and clinical studies, labeling, and stability data required for the IND application in eCTD format.
CTD AND ECTD IN QUALITY ASSURANCE BY INTHIYAZ RIPERInthiyazBegum
The document discusses the Common Technical Document (CTD) format and the Electronic Common Technical Document (ECTD) format for submitting documentation to regulatory agencies for drug approval.
The CTD format was agreed upon in 2000 and standardized the organization of documentation into five modules: quality, non-clinical studies, clinical studies, and regional administrative information. The ECTD format further standardized electronic submission in an internationally agreed upon format to facilitate review. Benefits of the CTD and ECTD formats include global harmonization, easier preparation and review of submissions, and reduced costs. Risks of electronic submissions include technical issues and ensuring documentation is properly formatted and validated.
The document discusses the Common Technical Document (CTD) format, which was created by the International Conference on Harmonisation to standardize the submission of documentation for drug approval across regions. It provides a five-module structure for organizing quality, safety, efficacy and other information. While CTD helped streamline submissions, the electronic CTD (eCTD) was later developed to further facilitate electronic transfer and review of documentation between regulators and industry. eCTD utilizes XML formatting and allows lifecycle management of submissions but implementation presents challenges around file formats, regional rules and last minute changes.
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.
The document discusses the Common Technical Document (CTD) format for organizing drug regulatory submissions. It notes that CTD was created to standardize submissions across regions and overcome issues like complex approval processes. CTD structures information into five modules covering administrative data, summaries, quality, nonclinical studies, and clinical studies. The document also describes the electronic CTD (eCTD) format and its benefits like improved submission and review processes through use of standardized electronic files and metadata. Implementation challenges include the need for specialized tools and training as well as varying regional requirements.
The document discusses the Common Technical Document (CTD) and Electronic Common Technical Document (eCTD) formats used for drug registration applications. The CTD format provides a standardized structure for organizing documentation, while the eCTD format digitizes the CTD for electronic submission. Both formats were developed through international harmonization efforts to streamline the drug approval process. The eCTD uses hyperlinks and an XML backbone to improve navigation of application materials compared to the paper-based CTD.
The document provides information on the Common Technical Document (CTD) format for organizing technical documents submitted to regulatory authorities for approval of pharmaceutical products. The CTD format was developed by the International Conference on Harmonization to streamline review processes and facilitate simultaneous submissions across different regions. It includes five modules covering administrative information, summaries, quality, nonclinical and clinical data. Adopting a common format provides benefits like reduced submission time and costs as well as faster availability of new medicines to patients.
The document discusses the Common Technical Document (CTD) and electronic CTD (eCTD) formats for submitting information on medicines to regulatory authorities. The CTD format was introduced in 2000 to harmonize dossier submissions across regions. It organizes information into five modules covering administrative data, quality and safety summaries, nonclinical and clinical study reports. The eCTD is the electronic version that allows electronic submission to improve the review process. Requirements for the eCTD include PDF version, formatting, hyperlinks and file naming conventions. Overall, the CTD and eCTD were created to standardize submissions and facilitate review of medicines by regulatory bodies.
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for new drug applications. The CTD format was agreed upon in 2000 and standardized the organization of application modules for quality, nonclinical, and clinical information. The eCTD is the electronic equivalent that regulatory agencies now require for application submissions. Key benefits of the eCTD include increased efficiency, reduced costs, and improved review processes through electronic submission and evaluation of drug applications.
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for registration dossier submissions. It provides background on the International Conference on Harmonization (ICH) and its role in harmonizing technical requirements for drug registration. The key points covered are:
1) The CTD format was created by ICH to provide a standardized common format for drug registration submissions across regions/countries.
2) The eCTD specification was later developed as the electronic equivalent of CTD to streamline the submission and review process.
3) Benefits of eCTD include improved handling of submissions, better information management, and increased efficiency of the evaluation and review process.
CTD and ECTD provide harmonized structures for new drug applications to regulatory agencies in the US, EU, and Japan. The Common Technical Document (CTD) organizes information into five modules covering administrative data, summaries, quality, nonclinical studies, and clinical studies. The Electronic Common Technical Document (eCTD) is the electronic version with XML formatting. It allows for increased transparency, searchability, and review efficiency compared to the paper CTD. Both CTD and eCTD aim to streamline the drug approval process across different regions.
The document discusses the Common Technical Document (CTD), which provides a standardized format for submitting documentation to regulatory authorities for approval of pharmaceutical products. It describes the evolution and adoption of the CTD internationally and in India. The CTD aims to streamline the drug approval process and facilitate simultaneous reviews by different regulators. It is organized into five modules covering administrative information, summaries, quality, nonclinical data, and clinical data. Widespread use of the CTD format has allowed for greater harmonization and efficiency in global pharmaceutical development and regulation.
The document summarizes key aspects of a drug dossier submission process. It explains that a dossier contains detailed information about a drug product that is submitted to regulatory authorities for market approval. It also describes the Common Technical Document (CTD) format, which is a harmonized template used for presenting dossier data. The CTD includes 5 modules that cover administrative information, summaries, quality, non-clinical studies, and clinical studies. Electronic CTD (eCTD) submissions using an XML backbone are now commonly accepted by major regulatory agencies.
The document summarizes key aspects of a drug dossier submission process. It explains that a dossier contains detailed information about a drug product that is submitted to regulatory authorities for market approval. It also describes the Common Technical Document (CTD) format, which is a harmonized template used for presenting dossier data. The CTD includes 5 modules that cover administrative information, summaries, quality, non-clinical studies, and clinical studies. Electronic CTD (eCTD) submissions using an XML backbone are now commonly accepted by major regulatory agencies.
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
The document discusses the Common Technical Document (CTD) format, which is a standardized format for submitting documentation to regulatory authorities for approval of pharmaceutical products. It originated from international harmonization efforts to streamline the drug approval process. The CTD format organizes information into five modules covering administrative information, summaries, quality/manufacturing, nonclinical data, and clinical data. It aims to reduce duplication and facilitate consistent reviews across regions. Submissions using the CTD format are now mandatory in major markets like the US, EU and Japan.
The document discusses the Common Technical Document (CTD), which is an internationally agreed format for organizing technical documents submitted to regulatory authorities for drug approval. It aims to harmonize submissions across regions to streamline the review process. The CTD format includes five modules covering administrative information, summaries, quality, nonclinical studies, and clinical studies. It provides benefits like reducing application preparation time and facilitating simultaneous multi-regional submissions and information exchange between authorities.
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
The document discusses the Common Technical Document (CTD), which is a standardized format for submitting regulatory information to the FDA, EMA, and MHLW. It provides an overview of the CTD, including its evolution, modules, advantages, and comparison to the electronic CTD format. The key points are:
1) The CTD is a standardized format adopted by the FDA, EMA and MHLW to streamline the submission and review of documentation for drug approval.
2) It is divided into 5 modules covering administrative information, summaries, quality, nonclinical and clinical data.
3) The electronic CTD (eCTD) allows for digital submission and navigation, remote access and faster
The document discusses the Common Technical Document (CTD), which is a standardized format for submitting regulatory information to the FDA, EMA, and MHLW. It provides an overview of the CTD, including its evolution, modules, advantages, and comparison to the electronic CTD format. The key points are:
1) The CTD is a standardized format adopted by the FDA, EMA and MHLW to streamline the submission and review of documentation for drug approval.
2) It is divided into 5 modules covering administrative information, summaries, quality, nonclinical studies, and clinical studies.
3) The electronic CTD (eCTD) allows for digital submission and remote access, facilitating
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.
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.
This document discusses dossier preparation and submission for regulatory approval of pharmaceutical products. It defines a dossier as a collection of documents on a subject used to propose approval of a new drug. Dossiers contain administrative, quality, nonclinical, and clinical data. Common dossier formats include CTD, ACTD, and eCTD, which are used globally and in various regions. Careful compilation, review, and planning is required to ensure dossiers meet all regulatory requirements for submission.
The document discusses the common technical document (CTD) format for submitting information to regulatory authorities for approval of drugs. The CTD format is an internationally agreed standard format consisting of five modules: general information, quality summaries, nonclinical study reports, clinical study reports, and appendices. Using a common format helps overcome hurdles by providing a standardized way for applicants to organize and submit the large amounts of documentation required for drug approval.
1. Dissolution and drug release tests measure the rate and extent of dissolution or release of a drug substance from a drug product in an aqueous medium under specified conditions.
2. The dissolution test is an important quality control procedure linked to how the drug product will perform in the body. It is often used to monitor drug product stability and manufacturing processes.
3. Several factors can affect drug dissolution and release, including drug substance properties, formulation excipients, test medium conditions, temperature, and apparatus type and settings. The most common apparatuses are rotating basket, rotating paddle, reciprocating cylinder, and flow cell.
Postmarketing surveillance (PMS) involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved for public use. PMS is important because pre-approval clinical trials involve relatively small numbers of participants and may not detect rare or long-term adverse effects. PMS uses various methods like spontaneous reporting, cohort studies, and case-control studies to monitor drug and device safety in larger populations over longer time periods after approval. The goal of PMS is to further evaluate or confirm the safety profile of products as they are used in real-world clinical settings by more diverse patients than clinical trials.
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for new drug applications. The CTD format was agreed upon in 2000 and standardized the organization of application modules for quality, nonclinical, and clinical information. The eCTD is the electronic equivalent that regulatory agencies now require for application submissions. Key benefits of the eCTD include increased efficiency, reduced costs, and improved review processes through electronic submission and evaluation of drug applications.
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for registration dossier submissions. It provides background on the International Conference on Harmonization (ICH) and its role in harmonizing technical requirements for drug registration. The key points covered are:
1) The CTD format was created by ICH to provide a standardized common format for drug registration submissions across regions/countries.
2) The eCTD specification was later developed as the electronic equivalent of CTD to streamline the submission and review process.
3) Benefits of eCTD include improved handling of submissions, better information management, and increased efficiency of the evaluation and review process.
CTD and ECTD provide harmonized structures for new drug applications to regulatory agencies in the US, EU, and Japan. The Common Technical Document (CTD) organizes information into five modules covering administrative data, summaries, quality, nonclinical studies, and clinical studies. The Electronic Common Technical Document (eCTD) is the electronic version with XML formatting. It allows for increased transparency, searchability, and review efficiency compared to the paper CTD. Both CTD and eCTD aim to streamline the drug approval process across different regions.
The document discusses the Common Technical Document (CTD), which provides a standardized format for submitting documentation to regulatory authorities for approval of pharmaceutical products. It describes the evolution and adoption of the CTD internationally and in India. The CTD aims to streamline the drug approval process and facilitate simultaneous reviews by different regulators. It is organized into five modules covering administrative information, summaries, quality, nonclinical data, and clinical data. Widespread use of the CTD format has allowed for greater harmonization and efficiency in global pharmaceutical development and regulation.
The document summarizes key aspects of a drug dossier submission process. It explains that a dossier contains detailed information about a drug product that is submitted to regulatory authorities for market approval. It also describes the Common Technical Document (CTD) format, which is a harmonized template used for presenting dossier data. The CTD includes 5 modules that cover administrative information, summaries, quality, non-clinical studies, and clinical studies. Electronic CTD (eCTD) submissions using an XML backbone are now commonly accepted by major regulatory agencies.
The document summarizes key aspects of a drug dossier submission process. It explains that a dossier contains detailed information about a drug product that is submitted to regulatory authorities for market approval. It also describes the Common Technical Document (CTD) format, which is a harmonized template used for presenting dossier data. The CTD includes 5 modules that cover administrative information, summaries, quality, non-clinical studies, and clinical studies. Electronic CTD (eCTD) submissions using an XML backbone are now commonly accepted by major regulatory agencies.
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
The document discusses the Common Technical Document (CTD) format, which is a standardized format for submitting documentation to regulatory authorities for approval of pharmaceutical products. It originated from international harmonization efforts to streamline the drug approval process. The CTD format organizes information into five modules covering administrative information, summaries, quality/manufacturing, nonclinical data, and clinical data. It aims to reduce duplication and facilitate consistent reviews across regions. Submissions using the CTD format are now mandatory in major markets like the US, EU and Japan.
The document discusses the Common Technical Document (CTD), which is an internationally agreed format for organizing technical documents submitted to regulatory authorities for drug approval. It aims to harmonize submissions across regions to streamline the review process. The CTD format includes five modules covering administrative information, summaries, quality, nonclinical studies, and clinical studies. It provides benefits like reducing application preparation time and facilitating simultaneous multi-regional submissions and information exchange between authorities.
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
The document discusses the Common Technical Document (CTD), which is a standardized format for submitting regulatory information to the FDA, EMA, and MHLW. It provides an overview of the CTD, including its evolution, modules, advantages, and comparison to the electronic CTD format. The key points are:
1) The CTD is a standardized format adopted by the FDA, EMA and MHLW to streamline the submission and review of documentation for drug approval.
2) It is divided into 5 modules covering administrative information, summaries, quality, nonclinical and clinical data.
3) The electronic CTD (eCTD) allows for digital submission and navigation, remote access and faster
The document discusses the Common Technical Document (CTD), which is a standardized format for submitting regulatory information to the FDA, EMA, and MHLW. It provides an overview of the CTD, including its evolution, modules, advantages, and comparison to the electronic CTD format. The key points are:
1) The CTD is a standardized format adopted by the FDA, EMA and MHLW to streamline the submission and review of documentation for drug approval.
2) It is divided into 5 modules covering administrative information, summaries, quality, nonclinical studies, and clinical studies.
3) The electronic CTD (eCTD) allows for digital submission and remote access, facilitating
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.
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.
This document discusses dossier preparation and submission for regulatory approval of pharmaceutical products. It defines a dossier as a collection of documents on a subject used to propose approval of a new drug. Dossiers contain administrative, quality, nonclinical, and clinical data. Common dossier formats include CTD, ACTD, and eCTD, which are used globally and in various regions. Careful compilation, review, and planning is required to ensure dossiers meet all regulatory requirements for submission.
The document discusses the common technical document (CTD) format for submitting information to regulatory authorities for approval of drugs. The CTD format is an internationally agreed standard format consisting of five modules: general information, quality summaries, nonclinical study reports, clinical study reports, and appendices. Using a common format helps overcome hurdles by providing a standardized way for applicants to organize and submit the large amounts of documentation required for drug approval.
1. Dissolution and drug release tests measure the rate and extent of dissolution or release of a drug substance from a drug product in an aqueous medium under specified conditions.
2. The dissolution test is an important quality control procedure linked to how the drug product will perform in the body. It is often used to monitor drug product stability and manufacturing processes.
3. Several factors can affect drug dissolution and release, including drug substance properties, formulation excipients, test medium conditions, temperature, and apparatus type and settings. The most common apparatuses are rotating basket, rotating paddle, reciprocating cylinder, and flow cell.
Postmarketing surveillance (PMS) involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved for public use. PMS is important because pre-approval clinical trials involve relatively small numbers of participants and may not detect rare or long-term adverse effects. PMS uses various methods like spontaneous reporting, cohort studies, and case-control studies to monitor drug and device safety in larger populations over longer time periods after approval. The goal of PMS is to further evaluate or confirm the safety profile of products as they are used in real-world clinical settings by more diverse patients than clinical trials.
Dissolution and drug release tests measure the rate and extent to which a drug substance is released from a drug product under specified conditions. They are important quality control tests linked to a product's in vivo performance. Factors like drug substance properties, formulation excipients, test medium conditions, temperature, and apparatus used can affect dissolution. Common apparatuses include rotating baskets or paddles for tablets/capsules, reciprocating cylinders for extended release products, and flow cells for low solubility drugs. Tests must match the drug product and simulate gastrointestinal or dermal conditions as needed.
Drug stability and stabilization techniques are important topics in pharmaceutical science. This document was written by Dr. Prakash S Goudanavar, a professor and head of the Department of Pharmaceutics and Regulatory Affairs at Sri Adichunchanagiri College of Pharmacy. The document will likely discuss factors that influence drug stability and methods used to stabilize drugs and extend their shelf life.
1. Absorption is the process by which drugs enter systemic circulation after administration. It is an important prerequisite for a drug to exert its pharmacological effects.
2. Drugs can be absorbed via passive diffusion, active transport, facilitated diffusion, or endocytosis. Key factors affecting absorption include drug solubility, permeability, and gastrointestinal physiology.
3. Formulation factors like dosage form, particle size, disintegration time, and storage conditions can also impact a drug's absorption rate and bioavailability.
This document discusses in vitro drug product performance characterization and dissolution testing of solid oral dosage forms. It describes the importance of in vitro testing in predicting in vivo drug absorption and performance. The key factors that can affect drug dissolution are described, including drug substance properties, formulation composition, manufacturing processes, and test conditions. Common dissolution apparatus, media, and acceptance tolerances used in testing immediate release solid oral drug products are also summarized.
Dissolution and drug release tests measure the rate and extent to which a drug substance is released from a drug product under specified conditions. These tests are important quality control procedures that can be linked to how a drug performs in the body. Factors like the drug's properties, formulation ingredients, test medium, temperature, and apparatus used can affect dissolution and release. Common apparatuses include baskets, paddles, cylinders, and flow cells, each suited for different drug product types like tablets, capsules, or transdermal patches.
1. Absorption is the process by which drugs enter systemic circulation after administration. It is an important prerequisite for a drug to exert its pharmacological effects.
2. Drugs can be absorbed via passive diffusion, facilitated transport, active transport, or endocytosis. Key factors like solubility, permeability, and gastrointestinal physiology influence absorption rates.
3. Formulation properties such as dosage form, particle size, disintegration time, and stability can also impact a drug's absorption from the gastrointestinal tract.
1. The document discusses in vitro characterization of solid oral drug products, focusing on factors that affect drug dissolution and release from these products. It covers the importance of dissolution testing, types of solid oral dosage forms, and factors related to drug substances, formulations, manufacturing processes, and dissolution test conditions.
2. Dissolution tests are described as important for evaluating drug product performance and predicting in vivo absorption. Key aspects of dissolution testing covered include test apparatus, media, and acceptance tolerances for immediate release products.
3. The factors discussed indicate that drug dissolution is a complex, multifactorial process influenced by properties of the active drug, dosage form design, and test conditions. Careful consideration of these factors is important
Generic drugs can be approved through an Abbreviated New Drug Application (ANDA) which relies on the safety and efficacy data of the branded drug. The ANDA process requires generic manufacturers to show bioequivalence to the branded drug through bioavailability and bioequivalence studies rather than completing full clinical trials. If bioequivalence is established, it demonstrates that the generic drug delivers the same amount of active ingredients into a patient's bloodstream in the same amount of time as the branded drug. The Hatch-Waxman Act established the modern ANDA approval process and aims to balance promoting generic drugs to reduce costs while also compensating branded manufacturers for regulatory time lost from patents.
This document discusses the process of generic drug product development. It explains that a generic drug is identical to the branded reference drug in terms of active ingredients, dosage form, safety and efficacy. The document then outlines several key steps in generic drug development, including selecting a product, ensuring API availability, developing analytical methods, conducting formulation development studies, manufacturing exhibit batches, conducting bioequivalence studies, and seeking regulatory approval from agencies like the FDA. It also discusses provisions of the Hatch-Waxman Act that aim to facilitate generic drug approval while compensating branded manufacturers.
This document discusses documentation practices in the pharmaceutical industry. It emphasizes that quality cannot be ensured without good documentation, which involves systematic interaction between people, events, and documents. Documentation includes procedural documents, instructions, records, and various regulatory requirements. Records provide legally valid evidence and help ensure quality and consistency. The document then discusses specific documentation requirements like master formula records, drug master files, and distribution records. It provides examples of required information and formats for documentation.
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
At Apollo Hospital, Lucknow, U.P., we provide specialized care for children experiencing dehydration and other symptoms. We also offer NICU & PICU Ambulance Facility Services. Consult our expert today for the best pediatric emergency care.
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MYASTHENIA GRAVIS POWER POINT PRESENTATIONblessyjannu21
Myasthenia gravis is a neurological disease. It affects the grave muscles in our body. Myasthenia gravis affects how the nerves communicate with the muscles. Drooping eyelids and/or double vision are often the first noticeable sign. It is involving the muscles controlling the eyes movement, facial expression, chewing and swallowing. It also effects the muscles neck and lip movement and respiration.
It is a neuromuscular disease characterized by abnormal weakness of voluntary muscles that improved with rest and the administration of anti-cholinesterase drugs.
The person may find difficult to stand, lift objects and speak or swallow. Medications and surgery can help the patient to relieve the symptoms of this lifelong illness.
Exploring the Benefits of Binaural Hearing: Why Two Hearing Aids Are Better T...Ear Solutions (ESPL)
Binaural hearing using two hearing aids instead of one offers numerous advantages, including improved sound localization, enhanced sound quality, better speech understanding in noise, reduced listening effort, and greater overall satisfaction. By leveraging the brain’s natural ability to process sound from both ears, binaural hearing aids provide a more balanced, clear, and comfortable hearing experience. If you or a loved one is considering hearing aids, consult with a hearing care professional at Ear Solutions hearing aid clinic in Mumbai to explore the benefits of binaural hearing and determine the best solution for your hearing needs. Embracing binaural hearing can lead to a richer, more engaging auditory experience and significantly improve your quality of life.
Healthy Eating Habits:
Understanding Nutrition Labels: Teaches how to read and interpret food labels, focusing on serving sizes, calorie intake, and nutrients to limit or include.
Tips for Healthy Eating: Offers practical advice such as incorporating a variety of foods, practicing moderation, staying hydrated, and eating mindfully.
Benefits of Regular Exercise:
Physical Benefits: Discusses how exercise aids in weight management, muscle and bone health, cardiovascular health, and flexibility.
Mental Benefits: Explains the psychological advantages, including stress reduction, improved mood, and better sleep.
Tips for Staying Active:
Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
Maintaining a Balanced Lifestyle:
Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
Michigan HealthTech Market Map 2024. Includes 7 categories: Policy Makers, Academic Innovation Centers, Digital Health Providers, Healthcare Providers, Payers / Insurance, Device Companies, Life Science Companies, Innovation Accelerators. Developed by the Michigan-Israel Business Accelerator
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdfDr Rachana Gujar
The "Comprehensive Rainy Season Advisory: Safety and Preparedness Tips" offers essential guidance for navigating rainy weather conditions. It covers strategies for staying safe during storms, flood prevention measures, and advice on preparing for inclement weather. This advisory aims to ensure individuals are equipped with the knowledge and resources to handle the challenges of the rainy season effectively, emphasizing safety, preparedness, and resilience.
2. 2
G L O S S A R Y
CTD – Common Technical Document
ICH - International Conference on Harmonisation
eCTD – Electronic Common Technical Document
NeES – Non-eCTD Electronic Submission
RIMS – Regulatory Information Management System
EMA - European Medicines Agency
NCA - National Competent Authorities
FDA - Food and Drug Administration
CDER - Center for Drug Evaluation and Research
CBER - Center for Biologics Evaluation and Research
SPL - Structured Product Labeling
XML – eXtensible Markup Language
XSL – eXtensible Stylesheet Language
DTD – Document Type Definition
4. 4
Regulatory Submissions
Why? Need to gain approval from Regulatory agencies to market
pharmaceutical drug products in their respective countries
When? Innovator discovers a new molecule, Formulator knows of a
patent expiration, API Manufacturer markets Drug Substance, Annual
Reports, Amendments, etc.
What? Administrative, prescription, manufacturing, CMC, quality, non-
clinical and clinical study information
How? Paper, Non-eCTD Electronic Submission (NeES), electronic
Common Technical Document (eCTD)
Whom? ICH Countries (US, EU, JP, CA) and Emerging Markets (TGA,
MCC, Africa, South East Asia, Latin America, etc.)
6. 6
Regulatory Submissions – contd.
Partial list of Regions and Countries for Regulatory Submissions
GCC (Saudi Arabia, Oman, UAE, etc.)
LEVANT (Turkey, Israel, Jordan, Lebanon, Palestine, Northern Cyprus, Syria)
ASEAN (Malaysia, Singapore, Thailand)
APAC (Australia, Brunei, Cambodia, etc.)
EU (England, Austria, Belgium, etc.)
CEE (Albania, Slovakia, Croatia, etc.)
Some important MoH Websites:
http://www.aseansec.org http://mccza.com/
http://www.sfda.gov.sa http://www.fda.gov
http://www.jfda.jo http://www.ema.europa.eu/ema/
http://www.hc-sc.gc.ca https://www.swissmedic.ch/
7. 7
History
Fast forward to early 2000, the International Conference on
Harmonization (ICH) has prepared a guideline on the
organization of a common technical document for
registration of pharmaceuticals for human use or a CTD.
Move forward to 2004, the ICH has issued another guideline
on the specifications and requirements for submission of a
marketing application in electronic form or the eCTD, which
has a designation of ICH M2.
In the year 2008, on January1 the FDA indicated that all
marketing application submissions were to be submitted
electronically in eCTD format.
8. 8
APPLICABILITY
Required in EU, Japan, and Canada for marketing
applications.
“Highly recommended” by FDA for NDA, BLA.
Required by CDER for eCTD submissions.
Required in EU (IMPD) and Canada for investigational
applications.
Accepted by FDA for IND.
9. 9
CTD Structure
CTD stands for Common Technical Document
It is a logical ordering and organization of information
It is a way of managing information at the document level
1. Came into effect in 2000
2. Adopted by ICH
(International Conference
on Harmonization)
3. Organization of the data
into modules and nodes
11. 11
Paper, NeES, eCTD
Paper NeES eCTD
Contains one or more volumes
with continuous table of contents
Contains folders with module and
global table of contents
Contains folders with XML based table
of contents
Printed documents are organized
using slip sheets, page separators
and cover letters
Published PDF documents are
organized into folders under
different modules and nodes
Same as NeES with separate provision
for accommodating Study Tagging
Files (STFs)
Up to 5 copies have to be
couriered to the agency
The entire application is to be
sent to the agency via the Drop
Box or on CD/DVD
Single sequence can be sent to FDA
via CD/DVD or Gateway (ESG).
No need to create bookmarks,
hyperlinks. Just a ToC will do
Need to strictly adhere to the
agency specified document
publishing guidelines
Same as NeES. Need to also create
cross-document and cross-application
hyperlinks for easy navigation
Agency can only validate the
contents of the dossier and not
the structure
Agencies have extensive
Validation criteria to accept
NeES.
Same as NeES. Also checks
checksums, file attribute, life cycle
operations, etc.
No tools are required to create a
paper submission
Sophisticated tools are required
to create and manage NeES
submissions
Same as NeES. In addition, the tool
must be 21 CFR Part 11 compliant
Has become the exception Still accepted by some NCAs Is the most preferred format
12. 12
Benefits of eCTD
Financial
Printing and shipping costs are eliminated
Application can be submitted in multiple countries with relatively minor changes
Reduce review times, increase your response times to Agency requests, and
ultimately lead to a faster approval
Improved Application Review Process
Most Agency reviewers prefer eCTD vs. paper
Submissions can be uploaded to the Electronic Submissions Gateway (ESG) and are
available to reviewers within hours
Thanks to bookmarks and hyperlinks, a reviewer can easily jump to the paper you
just cited, the table you just mentioned, or the validation report you just
referenced
Reviewers no longer have to search through countless paper volumes to
determine what changes have been made to an application
Convenience
Multiple people can access the same documents at the same time – no more
sharing paper volumes or making extra copies
Agency employees can access the application remotely, allowing reviewers to
continue their review regardless of their location
Agency can audit the software used to create the eCTD submission during site
inspections
16. 16
MODULE 2
Module 2
2.1 OVERALL CTD TABLE OF CONTENTS OF MODULES 2, 3, 4, AND 5
2.2 INTRODUCTION
2.3 QUALITY OVERALL SUMMARY
2.3.S DRUG SUBSTANCE
2.3.S.1 General Information
2.3.S.2 Manufacture
2.3.S.3 Characterization
2.3.S.4 Control of Drug Substance
2.3.S.5 Reference Standards or Materials
2.3.S.6 Container Closure System
2.3.S.7 Stability
2.3.P DRUG PRODUCT
2.3.P.1 Description and Composition of the Drug Product
2.3.P.2 Pharmaceutical Development
2.3.P.3 Manufacture
2.3.P.4 Control of Excipients
2.3.P.5 Control of Drug Product
2.3.P.6 Reference Standards or Materials
2.3.P.7 Container Closure System
2.3.P.8 Stability
26. 26
Global Submission Formats
Europe
Mandatory eCTD format for electronic-only submissions since January 1,
2010 for Centralized Procedure
Almost all member states/NCAs are ready to accept eCTD only submissions
since January 1, 2010
Since January 2013 and “Mandatory from March 2014″ all eCTD submissions
must be sent using the dedicated submission channels: eSubmission
Gateway or the related eSubmission Web Client
USA
eCTD most preferred format of eSubmission. Mandatory for IND
submissions.
Paper accepted as an exception and is extremely rare
Health Canada
“Co-Submissions” and “Hybrid Submissions” no longer accepted by HC since
January 1, 2010.
eCTD is the most preferred format of eSubmission
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Global Submission Formats – contd.
Saudi FDA
Starting on January 05, 2013, the eCTD will be accepted, which will
become the preferred submission format one year later (starting on
January 04, 2014).
Finally, starting from January 03, 2015, only eCTD will be accepted.
GCC Nations
Started accepting NeES submissions from Q1 of 2014.
Transition to eCTD expected to happen in 2015.
Australia (TGA) and South Africa (MCC)
TGA – Accepting NeES since 2011-12. Started accepting eCTD from
2015.
MCC - eCTD pilot phase completed in February 2014. Industry asked to
submit in eCTD from June 2014
Golden Rule: Once eCTD, always eCTD
33. Electronic Submissions to US
Application Types – FDA
IND (Investigational New Drug
Application)
NDA (New Drug Application)
ANDA (Abbreviated New Drug
Application)
DMF (Drug Master File)
BLA (Biological license
Application)
FDA recommends sponsors to
submit a pilot submission for
technical evaluation
Submission Types – FDA
Original Application
Amendment
Re-submission
Pre-submission
Annual Report
Establishment Description
Supplement
Efficacy Supplement
Labeling Supplement
CMC Supplement
Other
34. Electronic Submissions to US – contd.
Unique FDA Submission
Requirements:
Filled out Form 356h (ANDA)
Annotated Label and Proposed
Labeling Text
Side by Side comparison of
Labeling Text with RLD (ANDA)
Signed, Executed Batch Records
Study Tagging Files (STF)
Clinical Study Reports (CSR)
Case Report Form (CRF)
Section 5.3.7 Case Report Forms
no longer used
Application number is always 6
digits
All Drug Listings must be sent via
Electronic Submission Gateway
(ESG)
35. Electronic Submissions to EU
Procedure Types – EU
Centralised Procedure (CP)
A marketing authorisation granted under the
centralised procedure means the medicinal
product may be put on the market in all
Member States
Decentralised Procedure (DCP)
Use if application will be made to several
member states and product has not received
marketing authorization in any member state
at time of application
Mutual Recognition Procedure (MRP)
Use if application will be made to several
member states and product has received
marketing authorization in any member state
at time of application
National Procedure (NP)
Single application filed to single nation
under existing national laws
Unique EU Sub Requirements
Country Specific Envelope(s)
“Common” directory for files common to
all nations receiving the submission
File naming as per the pattern [country
code]-[document type code]-[variable
component].[file type extension]
Tracking Table mandatory for MRP and DCP
Submissions
Node Extensions allowed, especially in the
case of Module 5
Product Information has both country and
language designations
“To be Advised” can be used if procedure
number not provided by the RMS or NCA
Unique Agency Codes and Names
Drop Box facility available for submitting
dossiers online
37. Electronic Submissions to SFDA and GCC
Procedure Types – GCC
GCC Procedure (GP)
A marketing authorization granted under the
GCC procedure means the medicinal product
may be put on the market in all 6 Member
countries
National Procedure (NP)
Single application filed to single nation
under existing national laws
Typical Process Flow at GCC/SFDA
Specification - version 1.2
SFDA eCTD vs GCC NeES
KSA CTD GCC CTD
Module 1:
1.7.3 Titled as “certificate of
Analysis – Drug Substance /
Finished Product”
Module 1:
1.7.3 Titled as “certificate of
Analysis – Drug Substance”
Module 2:
2.5 Titled as “Clinical Overview”
Module 2;
2.6 Titled as “Non-Clinical written
& Tabulated Summaries”
Module 2:
2.5 Titled as “Overview of the
Nonclinical Strategy”.
2.6 Titled as “Non-Clinical written
& Tabulated Summaries:
Pharmacology, Pharmacokinetics,
Toxicology”
Module 3:
3.2.R Regional Information
Module 3:
3.2.R Regional Information
3.2.R.1 Alcohol Content
Declaration
3.2.R.2 Porcine/Pork-Content
origin
3.2.R.3 The Diluents and Coloring
agents in the product formula.
38. Electronic Submissions to HC
Submission Types – HC
Technical Validation is based on 4 levels
Error
Warning
Information
Ignore
Unique HC Requirements
“Co-Submission” and “Hybrid
Submission” discontinued
Pre-assigned application number not
required for pilot submissions
Application numbers are 6 digits and
are prefixed with “e”
Simple M1/CA folder structure
40. 40
eCTD – Processes and Technologies
Processes to be followed:
Global Strategy to launch drugs in single or multiple markets
Adherence to Current and Country Specific Guidance
Creating Checklists for Document Assimilation, Assembly and
Review
Have good experience in using eCTD Publishing Tools
Following SoPs for generation of WORD and PDF documents
Ensuring eCTD submission meets country specific Validation
Criteria
Maintain Communication with Health Authorities
Tools and Technologies to be used:
PDF Publishing and Compliance Tool
eCTD Publisher and Validator
eCTD Consolidated (All Sequence) Viewer
eCTD Import Utility
41. Regulatory Information Management
System (RIMS)
Product Registration
Management
Submission Archive
Agency Correspondence
Q&A Database
Document and
Content
Management
eSubmission Publishing
Submission Planning Tool
Portfolio Management
Master Data
Acceleration is the result of the capabilities working in harmony…
Product Quality Systems
Quality Management System
(QMS)
42. 42
Document Publishing Standards
All PDF documents must be between version 1.4 and 1.6
All PDF documents that have more than 5 pages must have bookmarks and a table
of contents that is linked to the respective pages. The bookmarks must generally
match the table of contents
The ZOOM levels for all the bookmarks and hyperlinks must be set to “Inherit
Zoom” only
The PDF document must be made searchable, or, should be OCRd if scanned and
saved as PDF file
The initial view should be set to “Bookmarks Panel and Page” if the PDF document
has bookmarks. Else, should be set to “Page only”
“Fast Web Access” and “Most Recent View” must always be enabled in all PDF
documents