The document discusses the International Conference on Harmonization (ICH) guidelines. ICH brings together regulatory authorities and pharmaceutical companies from Europe, Japan, and the US to discuss testing procedures for ensuring drug safety, quality, and efficacy. The guidelines cover Quality, Safety, Efficacy, and Multidisciplinary topics. They aim to harmonize technical requirements for drug approval across countries to reduce costs and duplication of testing while making safe, effective treatments more widely available. The Common Technical Document format was also created to standardize the submission of information to regulatory agencies in ICH regions.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
New drug application submitted by the manufacture of a drug to the FDA-after clinical trials have been completed –for a license to market the drug for a specified.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
New drug application submitted by the manufacture of a drug to the FDA-after clinical trials have been completed –for a license to market the drug for a specified.
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
Introduction to Pharma regulatory affairsGIBT India
It constitutes of basic introduction of regulatory affairs in pharmaceuticals, career in pharma regulatory affairs, job opportunities and future aspect. GIBTIndia offers job oriented e- learning courses. Kindly visit us at www.gibtindia.com
Introduction
Brief description of the drug and the therapeutic class to which it belongs
Chemical and pharmaceutical information
Animal Pharmacolog
Animal Toxicology
Human/Clinical Pharmacology phase I
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special Studies Geriatrics, pediatrics, pregnant or nursing women
Regulatory status in other countries
Prescribing information
Samples and Testing Protocol/s
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
The International Classification of Diseases (ICD) is a globally recognized system for classifying and coding diseases, health conditions, and related factors. It is maintained and updated by the World Health Organization (WHO) and serves several critical functions in healthcare and epidemiology. To describe the ICD comprehensively within 3000 characters, we'll cover its history, purpose, structure, and significance.
**History:**
The roots of the ICD can be traced back to the mid-19th century when various countries began documenting statistics on causes of death. The need for a standardized classification system became evident as different nations used their own systems, hindering international comparisons. The ICD was officially established in its modern form in 1948, with subsequent revisions and updates.
**Purpose:**
The primary purposes of the ICD are as follows:
1. **Disease Classification:** The ICD provides a systematic way to categorize diseases and health conditions. Each condition is assigned a unique code, which simplifies data collection and reporting.
2. **Clinical Diagnosis:** Healthcare professionals use the ICD to document and communicate diagnoses. This aids in patient care, medical billing, and insurance claims processing.
3. **Epidemiology:** The ICD is crucial for monitoring and analyzing disease patterns on a global scale. It helps identify emerging health threats, allocate resources, and develop public health policies.
4. **Health Statistics:** Governments and health organizations use the ICD to compile health statistics, such as causes of death and disease prevalence. This information guides healthcare planning and resource allocation.
**Structure:**
The ICD is organized into chapters, sections, and codes. The current version, ICD-10, is divided into 22 chapters, covering a wide range of health-related topics. Here's an overview of some key chapters:
- **Chapter I:** Certain infectious and parasitic diseases
- **Chapter II:** Neoplasms (cancers)
- **Chapter III:** Diseases of the blood and blood-forming organs
- **Chapter IV:** Endocrine, nutritional, and metabolic diseases
- **Chapter V:** Mental and behavioral disorders
- **Chapter VI:** Diseases of the nervous system
- **Chapter VII:** Diseases of the eye and adnexa
- **Chapter VIII:** Diseases of the ear and mastoid process
- **Chapter IX:** Diseases of the circulatory system
- **Chapter X:** Diseases of the respiratory system
- **Chapter XI:** Diseases of the digestive system
- **Chapter XII:** Diseases of the skin and subcutaneous tissue
- **Chapter XIII:** Diseases of the musculoskeletal system and connective tissue
- **Chapter XIV:** Diseases of the genitourinary system
- **Chapter XV:** Pregnancy, childbirth, and the puerperium
- **Chapter XVI:** Certain conditions originating in the perinatal period
- **Chapter XVII:** Congenital malformations, deformations, and chromosomal abnormalities
- **Chapter XVIII:** Symptoms, signs, and abnormal clinical and labor
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
Introduction to Pharma regulatory affairsGIBT India
It constitutes of basic introduction of regulatory affairs in pharmaceuticals, career in pharma regulatory affairs, job opportunities and future aspect. GIBTIndia offers job oriented e- learning courses. Kindly visit us at www.gibtindia.com
Introduction
Brief description of the drug and the therapeutic class to which it belongs
Chemical and pharmaceutical information
Animal Pharmacolog
Animal Toxicology
Human/Clinical Pharmacology phase I
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special Studies Geriatrics, pediatrics, pregnant or nursing women
Regulatory status in other countries
Prescribing information
Samples and Testing Protocol/s
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
The International Classification of Diseases (ICD) is a globally recognized system for classifying and coding diseases, health conditions, and related factors. It is maintained and updated by the World Health Organization (WHO) and serves several critical functions in healthcare and epidemiology. To describe the ICD comprehensively within 3000 characters, we'll cover its history, purpose, structure, and significance.
**History:**
The roots of the ICD can be traced back to the mid-19th century when various countries began documenting statistics on causes of death. The need for a standardized classification system became evident as different nations used their own systems, hindering international comparisons. The ICD was officially established in its modern form in 1948, with subsequent revisions and updates.
**Purpose:**
The primary purposes of the ICD are as follows:
1. **Disease Classification:** The ICD provides a systematic way to categorize diseases and health conditions. Each condition is assigned a unique code, which simplifies data collection and reporting.
2. **Clinical Diagnosis:** Healthcare professionals use the ICD to document and communicate diagnoses. This aids in patient care, medical billing, and insurance claims processing.
3. **Epidemiology:** The ICD is crucial for monitoring and analyzing disease patterns on a global scale. It helps identify emerging health threats, allocate resources, and develop public health policies.
4. **Health Statistics:** Governments and health organizations use the ICD to compile health statistics, such as causes of death and disease prevalence. This information guides healthcare planning and resource allocation.
**Structure:**
The ICD is organized into chapters, sections, and codes. The current version, ICD-10, is divided into 22 chapters, covering a wide range of health-related topics. Here's an overview of some key chapters:
- **Chapter I:** Certain infectious and parasitic diseases
- **Chapter II:** Neoplasms (cancers)
- **Chapter III:** Diseases of the blood and blood-forming organs
- **Chapter IV:** Endocrine, nutritional, and metabolic diseases
- **Chapter V:** Mental and behavioral disorders
- **Chapter VI:** Diseases of the nervous system
- **Chapter VII:** Diseases of the eye and adnexa
- **Chapter VIII:** Diseases of the ear and mastoid process
- **Chapter IX:** Diseases of the circulatory system
- **Chapter X:** Diseases of the respiratory system
- **Chapter XI:** Diseases of the digestive system
- **Chapter XII:** Diseases of the skin and subcutaneous tissue
- **Chapter XIII:** Diseases of the musculoskeletal system and connective tissue
- **Chapter XIV:** Diseases of the genitourinary system
- **Chapter XV:** Pregnancy, childbirth, and the puerperium
- **Chapter XVI:** Certain conditions originating in the perinatal period
- **Chapter XVII:** Congenital malformations, deformations, and chromosomal abnormalities
- **Chapter XVIII:** Symptoms, signs, and abnormal clinical and labor
ICH Guidelines of Quality, Safety, Efficacy and Multidisciplinary guidelines that implemented by International Council for Harmonisation. ich stands for the harmonisation of Technical requirements of Pharmaceuticals for Human use.
ICH GUIDELINES, ICH, INTERNATIONAL CONFERENCE ON HARMONIZATION, B PHARMA 6TH SEM, PHARMACEUTICAL QUALITY ASSURANCE
ICH and ICH guidelines
Need
Origin of ICH
Evolution of ICH
ICH members
Steps of ICH
STEP 1: Building Scientific Consensus
STEP 2: Agreeing on Draft Text
STEP 3: Consulting Regional Regulatory Agencies
STEP 4: Adopting Harmonized Guidelines
STEP 5: Implementing Guidelines in ICH Regions
Categories of ICH guidelines
A Study On Brand Switching And Consumer Preferences Towards Soft Drinks With ...Dr.K.Venkateswara raju
There is heavy competition between the soft drink majors Pepsi and Coke across India. Both follow a heavy advertisement laden strategy to increase their market share and reach to customers. With the recent entry of smaller and local brands, they are devising new strategies to retain their existing foothold in this segment. With the introduction of water sachets at KIRANA and pan shops, people may show decreased interest in soft drinks. In this paper we concentrated on the distribution process and market expansion and pricing strategies being devised and implemented at Hindustan COCA-COLA Beverages in VIJAYAWADA by gathering information from retail and KIRANA shops and also form sales and marketing managers regarding the strategies at the company. Distribution strategies involve understanding the various channels of distribution like Grocery, E&D (Eating and Dining) & Convenience stores and also the RED parameters used to assess the retailers. It covers the various coolers sizes available with the retailers in this region. Expansion Strategies include both horizontal and vertical and will enable the company to gain a competitive edge over others in the market by opening new outlets as well as increasing sales in the existing outlets. Pricing strategies involve fixing the price over brands and see that there is no cannibalization between brands as well as make sure that product range covers the entire price bands.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...
ICH
1. DR. K. VENKATESWARA RAJU
ICH – GUIDELINES
INTRODUCTION
ICH stands for “International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use”.
Which is international non-profit Association, which is unique in bringing
together the regulatory authorities and pharmaceutical industries.
Where European Union, Japan and the USA involve in scientific and technical
discussions of the testing procedures required to assess and ensure the safety,
quality and efficacy of medicines.
These are the three pillars on which the health of the patients depend.
ICH Guidelines accepted as law in several Countries to ensure and access the Q,
S, E of medicines but are only used as guidance for the U.S Food and Drug
Administration.
Need to Harmonize
Many time-consuming and expensive test procedures, in order to market new
products, internationally.
Over rising costs of health care making safe and efficacious new treatments
available to patients in need.
Divergence in technical requirements from country to country.
ORIGIN OF ICH
Harmonization of regulatory requirements was pioneered by the EU, Europe, in
the 1980s as the Europe move towards the development of single market.
The success achieved in Europe demonstrated that harmonization was feasible.
2. At the same time there were discussions between Europe, Japan and the US on
possibilities for harmonization.
The birth of ICH took place at a meeting in April 1990.
ICH MEMBERS
EU
EFPIA (European federation of pharmaceutical industries’ associations).
MHLW (Ministry of health, Labor and welfare, Japan).
JPMA (Japan Pharmaceuticals manufacturers Association).
US FDA.
PhRMA (pharmaceutical research and manufacturers association).
Observers: WHO, TPP (Canada).
International federation of Pharmaceutical manufacturers association.
OBJECTIVES OF ICH
Promote public health by early availability of drug in the market.
Improve efficiency of new drug development, Reduce registration cost.
Less expensive drugs for patients.
Prevent the duplication of clinical trials in humans.
Minimize the animal use without compromising in safety, efficacy of the product.
Mutual acceptance of clinical data by regulatory authority.
Reducing testing duplication.
3. The guidelines of ICH are broadly categorized into four types.
QUALITY GUIDELINES
Harmonisation achievements in the Quality area include pivotal milestones such
as the conduct of stability studies, defining relevant thresholds for impurities
testing and a more flexible approach to pharmaceutical quality based on Good
Manufacturing Practice (GMP) risk management.
Safety Guidelines
ICH has produced a comprehensive set of safety Guidelines to uncover potential
risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough
has been a non-clinical testing strategy for assessing the QT interval prolongation
liability: the single most important cause of drug withdrawals in recent years.
Efficacy Guidelines
The work carried out by ICH under the Efficacy heading is concerned with the
design, conduct, safety and reporting of clinical trials. It also covers novel types
of medicines derived from biotechnological processes and the use of
pharmacogenetics/genomics techniques to produce better targeted medicines.
Multidisciplinary Guidelines
Those are the cross-cutting topics which do not fit uniquely into one of the
Quality, Safety and Efficacy categories. It includes the ICH medical terminology
(MedDRA), the Common Technical Document (CTD) and the development of
Electronic Standards for the Transfer of Regulatory Information (ESTRI).
4. QUALITY GUIDELINES
Q1A - Q1F: Stability
Q2: Analytical Validation
Q3A - Q3D: Impurities
Q4 - Q4B: Pharmacopoeias
Q5A - Q5E: Quality of Biotechnological Products
Q6A- Q6B: Specifications
Q7: Good Manufacturing Practice
Q8: Pharmaceutical Development
Q9: Quality Risk Management
Q10: Pharmaceutical Quality System
Q11: Development and Manufacture of Drug Substances
Q12: Lifecycle Management (DRAFT FORM)
Q13: Continuous Manufacturing of Drug Substances and Drug Products
(CONCEPT PAPER)
Q14: Analytical Procedure Development (CONCEPT PAPER)
SAFETY GUIDELINES
S1A - S1C: Carcinogenicity Studies
S2: Genotoxicity Studies
S3A - S3B: Toxicokinetic and Pharmacokinetics
S4: Toxicity Testing
S5: Reproductive Toxicology
S6: Biotechnological Products
S7A - S7B: Pharmacology Studies
S8: Immunotoxicology Studies
5. S9: Nonclinical Evaluation for Anticancer Pharmaceuticals
S10: Photo safety Evaluation
S11: Nonclinical Pediatric Safety
EFFICACY GUIDELINES
E1: Clinical Safety for Drugs used in Long-Term Treatment
E2A - E2F: Pharmacovigilance
E3: Clinical Study Reports
E4: Dose-Response Studies
E5: Ethnic Factors
E6: Good Clinical Practice
E7: Clinical Trials in Geriatric Population
E8: General Considerations for Clinical Trials
E9: Statistical Principles for Clinical Trials
E10: Choice of Control Group in Clinical Trials
E11 - E11A: Clinical Trials in Pediatric Population
E12: Clinical Evaluation by Therapeutic Category
E14: Clinical Evaluation of QT
E15: Definitions in Pharmacogenetics / Pharmacogenomics
E16: Qualification of genomic biomarkers
E17: Multi-Regional Clinical Trials
E18: Genomic Sampling
6. MULTIDISCIPLINARY GUIDELINES
M1: MedDRA Terminology
M2: Electronic Standards
M3: Nonclinical Safety Studies
M4: Common Technical Document.
M5: Data Elements and Standards for Drug Dictionaries
M6: Gene Therapy
M7: Mutagenic impurities
M8: Electronic Common Technical Document (eCTD)
M9: Biopharmaceutics Classification System-based Biowaivers
M10: Bioanalytical Method Validation
The Impact of ICH (Quality) on industry:
1. The ICH guidelines in the quality area have provided recommendations in two of
the key areas that define bulk drug and drug product quality- stability data and
impurities- and led to significant reduction in duplicate testing.
2. Prior to there was no harmonized approach to the data requirements in these
areas. With stability for example, it was typical to run studies at “room
temperature” as defined by the company concerned, and appropriate to the
locality.
3. There was also no humidity control. This resulted in registrations in different
regions requiring new stability data if the climatic zone was different to that
where the original study had been conducted.
7. 4. ICH harmonization provided standard sets of conditions taking account of the
climatic zones in each of the three regions.
5. This means that the information on stability generated in any one of the three
regions is mutually acceptable in the other two areas, provided it meets the
requirements of the guideline. This removed the duplicate testing.
6. The impurities guidelines [Impurities in New Drug Substances (Q3A), Impurities
in New Drug Products (Q3B), and Impurities: Guideline for Residual Solvents
(Q3C)] also served, as with the stability guidelines, to provide scientific
agreement on the recording and reporting of impurity levels.
7. Guidelines were also provided on how changes in impurity profile over the course
of a development program should be managed. The result of this is that it should
be possible to determine a single specification for any drug substance or product
that is acceptable across the three ICH regions. This makes the supply chain far
simpler, and minimizes supply error.
8. The ICH has also produced a parallel set of guidelines covering the specification
issues associated with biotechnological products. Standardization through the
guidelines has been a very positive step for the biotechnology industry, and has
certainly had a significant favorable impact on both development times and
resource utilization.
9. Duplication of research was reduced related to the stability testing, impurity
profiles.
ICH STABILITY GUIDELINES
8. Definitions and storage
conditions for four climatic
zones:-
Storage conditions for general
case:-
Type of study Storage Condition Minimum time period covered
by data at submission
Long term 30ºC ± 2ºC and 65%RH ± 5%RH 12 Months
Accelerated 40ºC ± 2ºC and 75%RH ± 5%RH 6 Months
Climatic Zone Definition Storage Condition Examples
I Temperate climate 21ºC ± 2ºC and
45%RH ± 5%RH
Northern Europe,
Canada.
II Mediterranean and
subtropical climate
25ºC ± 2ºC and
60%RH ± 5%RH
Southern Europe, US,
Japan.
III Hot dry climate 30ºC ± 2ºC and
35%RH ± 5%RH
Egypt, Sudan.
IV Hot and humid
climate
30ºC ± 2ºC and
75%RH ± 5%RH
Central Africa, south
Pacific.
9. Common technical document
Introduction:
Common technical document (CTD) is a format that was created by the ICH in an
attempt to harmonize the format of a drug approval’s applications in all 3 ICH
regions , i.e. the USA, Europe, and japan. The CTD was agreed upon in November
2000, in san Diego, California, the USA.
CTD is a common format/ template to provide the information to the drug regulatory
authorities in the 3 ICH regions. It is not a “single” dossier, with a “single” content
since legal requirements and applicant preferences differ in the 3 different ICH
regions.
The CTD as defined by the ich m4 expert working group(EWG)does not cover the
full submission that is to be made in a region.it describes only module 2 to 5, which
are common across all regions. The CTD does not describe the content of module 1
, the regional administrative information and prescribing information, nor does it
describe documents that can be submitted as amendments or variations to the initial
application.
The CTD is a set of specifications for the submission of regulatory data in the
application for obtaining market approval for pharmaceuticals. the format of the
CTD is not to be confused with its content or submission type, rather ,it is the means
by which information in a submission is organized.
Specifications for the organization of content of CTD
For modules 2-5, the ICH specifies the organization and content for CTD. For
module 1, the ICH specifies the regional sections, the specific regulatory authority
(i.e. FDA, Singapore, health Canada and india) specifies the organization and
content for CTD, therefore regional section content may vary between different ICH
regions.
Objectives of ICH behind CTD
10. 1. To present a well-structured common format for the preparation for
approvals applications which will be submitted to regulatory authorities.
2. To significantly reduce the time and resources needed to compile
applications for registration of human pharmaceuticals and ease the
preparation of electronic submissions.
3. To facilitate the regulatory reviews and communication with the applicant
by using a standard document of common elements.
4. To prevent unnecessary duplication of work.
Benefits of the CTD
1.Complete, well organized submissions
2. More predictable format
3.More consistent reviews
4.Easier analysis across applications
5.Eaiser exchange of information
6.Facilitates electronic submissions
11. ORGANIZATION OF THE COMMON TECHNICAL DOCUMENT
The common technical document is organized in to five modules
OBJECTIVES OF CTD GUIDELINE
This guideline is intended to provide recommendations on how to use stability
data generated in accordance with the principles detailed in the ICH guideline
Q1A(R) stability testing of new drug substances and products.
MODULE 1
A regional specific module containing administrative information,
and is unique to each regulatory authority.
MODULE 2
Contains overviews, written summaries and tabulated summaries
of the data contained in modules3,4 and 5
MODULE 3
Contains quality data relating to the drug substances and drug
product
MODULE 4
Contains non clinical data
MODULE 5
Contains clinical date
12. Stability protocol and report
1.Batches tested
2.General information
3.Container/closure system
4.Literature and supporting data
5.Stability-indicating analytical method
6.Testing plan
7.Test parameters
8.Test results
9.Other requirements (Post -approval commitments)
10.Conclusion