Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.Audumbar Mali
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
B. Pharm. Final Year, Sem-VIII, BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory),
As PCI Syllabus.
Registration of Indian Drug Product in Overseas Market.pptxNipun Gupta
This includes the following contents:
1. Introduction
2. Procedure for Export of products
3. Technical Documentations
MFR, BMR, COA, COPP
4. Drug Master File
5. Common Technical Document
6. Electronic Common Technical Documents
7. ASEAN Common Technical Document
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.Audumbar Mali
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
B. Pharm. Final Year, Sem-VIII, BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory),
As PCI Syllabus.
Registration of Indian Drug Product in Overseas Market.pptxNipun Gupta
This includes the following contents:
1. Introduction
2. Procedure for Export of products
3. Technical Documentations
MFR, BMR, COA, COPP
4. Drug Master File
5. Common Technical Document
6. Electronic Common Technical Documents
7. ASEAN Common Technical Document
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Pharma Malpractices - Report of the Parliament Committee to Rajya Sabha Anup Soans
Read this to understand the reasons for the Govt's crackdown on Indian Pharma - Parliament committee report on CDSCO. Parliament was seized of unethical and unprofessional practices in 2012 itself.
National Formulary of Unani Medicine is standard Unani Pharmacopeia published by Department of AYUSH, Ministry of Health &FW, Government of India in 2011
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Basic phrases for greeting and assisting costumers
Pharmaceutical regulatory authorities of India
1. Pharmaceutical Regulatory Authorities
Of India
SEMINAR PRESENTATION
Prepared by:- Rutuja Nale
First year
M.Pharm semester 2 (PQA)
Rajarambapu College Of Pharmacy
Kasegaon
Guided by:- Prof. Archna Dhole
1
Date :- 8 June 2021
2. 2
Content:-
• Introduction
• Regulatory Bodies
1. Central drug standard control organization (CDSCO)
2. Indian pharmaceutical association (IPA)
3. Drug technical advisory board (DTAB)
4. Central drug testing laboratory (CDTL)
5. Indian pharmacopoeia commission (IPC)
6. National pharmaceutical pricing authority (NPPA)
7. Indian council of medical research (ICMR)
• DETAILS OF
1. World health organization (WHO)
2. AYUSH
3. ICMR
3. India’s Ministry of Health and Family Welfare (MoHFW)
1. Central drug standard control organization
(CDSCO)
2. Indian pharmaceutical association (IPA)
3. Drug technical advisory board(DTAB)
4. Central drug testing laboratory (CDTL)
5. Indian pharmacopoeia commission (IPC)
6. National pharmaceutical pricing authority (NPPA)
7. Indian council of medical research (ICMR)
3
7. 7
• CDSCO is constantly thriving upon to bring out transparency,
accountability and uniformity in its services in order to ensure safety,
efficacy and quality of the medical product manufactured,imported
and distributed in the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for
approvalof Drugs, Conduct of Clinical Trials, laying down the
standards for Drugs, control over the quality of imported Drugs in the
country and coordination of the activities of State Drug Control
Organizationsby providing expert advice with a view of bring
about the uniformity in the enforcement of the Drugs and Cosmetics
Act.
8. 8
• Sugam builds a comprehensive database of the various permissions and
licenses issued by State FDAs.
• This includes details of manufacturers, manufacturing site and drug
formulations.
• Manufacturer can view their consolidated data about permissions issued
to them from State FDA.
9. INDIAN PHARMACEUTICAL ASSOCIATION
9
• Connecting The Pharmacistsand Pharmaceutical Scientists of India — The
Indian PharmaceuticalAssociation (IPA) is the National body representing
over 1 million pharmacists and pharmaceuticalscientists from Industry,
Academia, Regulatory, Hospital and Community Pharmacy and work to
meet the India’s health care needs.
• IPA is a non-governmentalorganization that has been in official relations
with the FIP and WHO.
• IPA is member of Drug Technical Advisory Board (DTAB), Ministry of Health
and Family Welfare, Government of India.
• IPA has been awarded “Best Professional Organisation Award -2015” by
Indian Association Congress.
11. Drugs Technical Advisory Board
•Drugs Technical Advisory Board is a statutory body constituted under the Drugs and Cosmetics
Act, 1940.
•The function of DTAB is to advise the Central government and State government on technical
matters related to drugs and cosmetics.
Section 3 of the Drugs and Cosmetics Act, 1940
•The Central Government, after consultation with
the Drugs Technical Advisory Board (DTAB),
specifies the devices intended for use in human
beings or animals as drugs.
11
12. 1.Central Drugs Testing Laboratory, Mumbai, Maharashtra
2.Central Drugs Laboratory, Kolkata, West Bengal
3.Central Drugs Testing Laboratory, Chennai, Tamil Nadu
4.Central Drugs Testing Laboratory, Hyderabad, Andhra Pradesh
5.Central Drugs Laboratory, Central Research Institute, Kasauli, Himachal
Pradesh
6.Regional Drugs Testing Laboratory, Guwahati, Assam
7.Regional Drugs Testing Laboratory, Chandigarh
A. Central Drugs Testing Laboratories
12
15. The National Pharmaceutical Pricing Authority (NPPA) is a government regulatory agency that
controls the prices of pharmaceutical drugs in India.[1].National Pharmaceutical Pricing Authority
(NPPA) was constituted vide Government of India Resolution dated 29th August, 1997 as an
attached office of the Department of Pharmaceuticals (DoP), Ministry of Chemicals and
Fertilizers as an independent Regulator for pricing of drugs and to ensure availability and
accessibility of medicines at affordable prices.
15
16. The World Health Organization is a specialized agency of the United Nations responsible for
international public health. The WHO Constitution, which establishes the agency's governing
structure and principles, states its main objective as "the attainment by all peoples of the highest
possible level of health".
What is the WHO definition of health?
Health is a state of complete physical, mental and social well-being and not merely the
absence of disease or infirmity.
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18. The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for
the formulation, coordination and promotion of biomedical research, is one of the oldest
medical research bodies in the world.
The Council's research priorities coincide with the National health priorities, such as: control and
management of communicable diseases, fertility control, maternal and child health, control of
nutritional disorders, developing alternative strategies for health care delivery, containment
within safety limits of environmental and occupational health problems; research on major non-
communicable diseases like cancer, cardiovascular diseases, blindness, diabetes and other
metabolic and haematological disorders; and mental health research and drug research
(including traditional remedies).
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