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Regulatory requirements forAPI and Biologics
Presented By
Simran
M.Pharm Ist year
GGSCOP,YNR
REGULATORY REQUIREMENTS FOR API
Introduction
Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food
supplements – all these products are subject to regulations designed by governments to protect
public health. For producing drug products of high quality, safety, and efficacy every industry
needs to follow regulations. The Regulatory Affairs department is an important part of the
organizational structure of pharmaceutical companies. At the late stage of product development
regulatory professionals are responsible for the submission of the dossier for registration, e.g.
Marketing Authorization Applications (MAA) in the EU or New Drug Applications (NDA) in the
US.
Regulatory guideline is an organization’s adherence to laws, regulations, guidelines, and
specifications relevant to its business.
The adoption of a global regulatory framework for active pharmaceutical ingredients (APIs) can
only be of benefit to the licensing authorities, the industry, and – last but not least – the patient.
Active pharmaceutical ingredients (APIs) are the constituents that give medicinal products and
their pharmacological activity. For this reason, the quality and stability of APIs are crucial factors
in the overall quality, safety, and efficacy of medicinal products
Essentially a biological comprises, contains or is derived from human cells or human tissues and
is used to treat or prevent disease, defect or injury; or diagnose the condition of a person; or
influence, inhibit or modify a physiological process in persons; or test the susceptibility of
persons to a disease or ailment; or replace or modify parts of the anatomy in persons.
A Novel Drug or a New Molecular Entity (NME) is an active compound, a complex, molecule
that previously has not been approved by the FDA/EMA.
• They are still considered Novel Drugs since the extensive characterization of the
pharmacological properties of that drug was carried out.
General work profile of a Regulatory Affairs
professional in an API manufacturing company
 Filing a DMF/ASMF with regulatory agencies in support of the NDA / ANDA/ INDA /MAA
filed by a Formulator (Drug Product manufacturer who uses API of that particular API
manufacturing company).
 Filing dossier of API with EDQM for obtaining CEP.
 Assessing and filing amendments/variations to the information (which may be related to
manufacturing, control, stability studies, etc) in DMF/ASMF/Dossier of particular API with the
Regulatory agencies. Major amendments are to be reported prior to their implementation while
minor amendments may be reported annually.
 Taking approval of customers of API before implementing any major changes regarding the
information mentioned in DMF/ASMF/Dossier. The updated DMF/ASMF may be submitted to
the customer simultaneously along with amendments/variations filed with the agency
Active Pharmaceutical Ingredient (API or drug
substances)
Any substance or mixture of substances intended to be used in the manufacture of a
pharmaceutical dosage form and that, when used so, becomes an active ingredient of that
pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or
other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect
the structure and function of the body .
Regulatory Guidelines forAPIs
In order to obtain marketing authorisation for a drug product the applicant has to show evidence
of efficacy, safety, and quality of the drug product
Different countries have different procedures for regulatory filing for API, in U.S. it has done as
per the DMF procedure of the FDA while in Europe it is done by ASMF procedure.
The older and off-patent APIs have an alternative assessment system called the “Certification of
Suitability” (CEP). It is used in the countries that have signed the European Pharmacopoeia
Convention.
NDA
 Since 1938, every new drug has been the subject of an approved NDA before U.S.
commercialization
 The NDA application is the vehicle through which drug sponsors formally propose that the
FDA approve a new pharmaceutical for sale and marketing in the U.S.
 The data gathered during the animal studies and human clinical trials of an Investigational New
Drug (IND) become part of the NDA
Drug Master File or DMF
A Drug Master File (DMF) is a set of documents that provides detailed information concerning
facilities, protocols, and procedures used in the manufacturing, packaging, and storing of
pharmaceuticals.
DMF is a submission to the FDA of information, usually concerning the Chemistry,
Manufacturing, and controls of a component of a drug product, to permit the FDA to review this
information.
Role of Drug Master Files
The Drug Master File (DMF) system was developed to permit suppliers to make this information
on their products directly available to FDA for its review of drug company applications that
involve the use of the supplier's material.
There is no regulatory requirement to file a DMF. However, the document provides the regulatory
authority with confidential, detailed information about facilities, processes, or articles used in the
manufacturing, processing, packaging, and storing of one or more human drugs.
Typically, a DMF is filled when two or more firms work in partnership on developing or
manufacturing a drug product.
The DMF should contain all the detailed information expected by the regulatory authorities so that a
DMF reference in an NDA or ANDA can be used to complete an agency review process. In the United
States, there is no approval process for a DMF.
In fact, DMFs are only examined when referenced in other regulatory filings, such as an NDA or
ANDA; then only that particular DMF with its unique reference no. is traced and reviewed.
If the drug is approvable, FDA headquarters may request an inspection to be taken place at an API
manufacturing site after a review of the DMF.
Types Of DMF’s
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation,
or Drug Product
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDAAccepted Reference Information
Requirements for Registration of API
In the US active pharmaceutical ingredient is referred to as a drug substance. Registration of
active substances takes place along with pre-marketing approvals like NDA & ANDA. That
means there is no separate registration process for API. The manufacturer of API need to submit
the information in the form of DMF. The FDA reviews the information and gives the DMF
number. When the drug product manufacturer wants to get approval for the product, they mention
the DMF of the drug substance as a supporting document for the applications like NDA &
ANDA.
Generally DMFs have two parts:
1. Applicant’s part: which contains non-confidential information that the license holder needs to
assess for the marketing.
1. Restricted part: which contains confidential information about the manufacturing procedure
that only needs to be disclosed to the authorities.
Registration requirements of DMF:
Each DMF submission should contain
A. Transmittal letter
B. Administrative information about the submission
A. Transmittal Letters
The following should be included:
1. Original Submissions
2. Amendments
1. Original submission:
i. Identification of submission: Original, the type of DMF as classified in Section III, and
its subject.
ii.Identification of the applications, if known, that the DMF is intended to support,
including the name and address of each sponsor, applicant, or holder, and all relevant
document numbers
iii.Signature of the holder or the authorized representative.
iv.Typewritten name and title of the signer.
2. Amendments
i. Identification of submission: Amendment, the DMF number, type of DMF, and the
subject of the amendment.
ii.A description of the purpose of submission, e.g. updates, revised formula, or revised
process.
iii.Signature of the holder or the authorized representative.
iv.Typewritten name and title of the signer.
B. Administrative Information
Administrative information should include the following:
1.Original Submission
2.Amendment
1. Original Submissions
a. Names and addresses of the following:
i. DMF holder.
ii. Corporate headquarters.
iii.Manufacturing/processing facility.
iv.Contact for FDA correspondence.
v.Agent(s), if any.
b. The specific responsibilities of each person are listed in any of the categories in Section a.
c. Statement of commitment- A signed statement by the holder certifying that the DMF is current and that the
DMF holder will comply with the statements made in it.
2. Amendments
i. Name of DMF holder.
ii. DMF number.
iii. Name and address for correspondence.
iv. Affected section and/or page numbers of the DMF.
v. The name and address of each person whose IND, NDA, ANDA, DMF, or Export Application relies on the
subject of the amendment for support.
Filing of DMF
 Recent update regarding USFDA DMF is now we can submit eCTD via ESG (Electronic
Submission Gateway).
 The deadline for the conversion of Paper format to e-CTD is beginning May 5, 2017, all
submission types NDA, ANDA, BLA, and Master Files must be submitted in eCTD format.
Regulatory Requirements For BIOLOGICS
Biologics
•Biologics are the products manufactured, extracted from, or semi-synthesized from a biological
source that is regulated by FDA and are used to prevent cure and treat diseases and medical
conditions.
•These are generally large, complex molecules produced through biotechnology in a living system
such as a microorganism, plant cell, or animal cell.
•These could be made of sugars, proteins, nucleic acids, or complex combinations of these
substances or may be living entities.
•These are complex mixtures that are not easily identifiable and characterized these tend to be heat
sensitive and susceptible to microbial contamination hence, it is necessary to use aseptic
principles from the initial manufacturing process.
•EXAMPLES: Botox, Herceptin, Vaccines, Enbrel
Sources
 Mammalian cell culture
 Bacteria
 Insect cell culture
 Plant cell culture
 Yeast
 Transgenics
 Avian cell culture
 Humans
Types
 Blood derivatives
 Vaccines
 Allergenic extracts
 Whole blood
 Blood components
 Proteins
 Human tissues
 Cellular and gene therapies
 Xeno-transplantation products
Difference b/w biologics & chemical drug
Properties Biologics Chemical drug
Size Large Small
Structure Complex Simple
Stability Unstable Stable
Modification impossible to ensure
identical copy
identical copy made
Manufacturing Many options Well defined
Characterization Impossible Easy
Biologics and its regulatory guidelines
Biologic/ Biologics / biological product
Biological Product is a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
component or derivative, allergenic product, or analogous product, applicable to the prevention,
treatment, or cure of a disease or condition of human beings.
Law orAct
▪ Drug Products
fall under the Food, Drug, and Cosmetic Act.
While
▪ Biological products
Fall under the Food, Drug, and Cosmetic Act & Public Health Service Act
USFDA Biologics Team
The FDA biologics team was established in 1997 to assure the quality and safety of Biological
products
It consists of a core team of,
1. Certified ORA investigator,
2. CBER-certified inspectors, and
3. Specially trained compliance officers representing both ORAAND CBER
Regulatory authority for biologics
Centre for biologics evaluation and research (CBER) is the center within FDA that regulates biological
products for human use under applicable Federal laws including the Public Health Services Act (PHS)
and the Federal, Food, Drug, and Cosmetics Act
CBER protects and advances public health by ensuring that biological products are safe and effective.
FDA's regulatory authority for the approval of biologics resides in (PHS) Act.
Biologics are subjected to regulation under the Federal, Food, Drug, And Cosmetics act (FD&C) Act.
Some medical devices which are used to produce biologics are regulated by CBER under the FD&C
Act’s medical device amendments of 1976.
FDA also reviews new biological products and new indications and usage for already approved
products on the market for the treatment of known diseases.
It protects against threats of emerging infectious diseases.
It provides the public with information to promote the safe and appropriate use of COPS DSU
Department of Pharmaceutics
Development and approval process
 Advertising and Labelling
 Investigational New Drug Application (IND) or Device exemption process (IDE)
 Expanded Access
 Premarket Approval (PMA)
 Biologics License Application (BLA) New Drug Application Process (NDA).
 Biologics Approvals By Year.
Biologics license application (BLA)
 The Biologics License Application (BLA) is a request for permission to introduce or deliver
for introduction a Biologic product into the market.
 It is mainly regulated by 21 CFR 600-800. It is submitted by any legal person or entity, who
engaged in the manufacture or an applicant for a license who takes responsibility for
compliance with the product and establishment of standards
 A Biologic License application generally applies to vaccines and other Allergenic drug
products and cellular and genetic therapies.
 A cover letter should always accompany any FDA submission. Addressed below are Form
FDA 356(h), the cover letter, and all 20 sections of the BLA application.
 Before each section is addressed individually, it is worth emphasizing the importance of the
application form [Form FDA 356(h)], the cover letter, and the first three sections.
 Under the Public Health Services Act, the Federal Food and Drug Administration (FDA) has been given the
authority, concurrent with its authority under the Food Drug and Cosmetic Act, to regulate biologics.
 The FDA regulates a wide range of biologics, including vaccines, blood, and blood by-products, certain
monoclonal antibodies, and tissue and cellular products.
 within the FDA, the Center for Biologics as well as the Centre for Drug Evaluation and Research, can be
responsible for the regulation of biologics.
 Biologics are evaluated for market by the FDA through the filing of a Biologic License Application (BLA).
 A BLA, although similar to a New Drug Application (NDA), has its own set of complex requirements.
 Applicant has to provide the information in an acceptable format, under the applicable regulations. However,
applicants must be aware that unique and specific information will be required depending on the type of BLA (e.g.
– blood, vaccines).
THANK
YOU

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Regulatory requirements for API and Biologics

  • 1. Regulatory requirements forAPI and Biologics Presented By Simran M.Pharm Ist year GGSCOP,YNR
  • 3. Introduction Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. For producing drug products of high quality, safety, and efficacy every industry needs to follow regulations. The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. At the late stage of product development regulatory professionals are responsible for the submission of the dossier for registration, e.g. Marketing Authorization Applications (MAA) in the EU or New Drug Applications (NDA) in the US. Regulatory guideline is an organization’s adherence to laws, regulations, guidelines, and specifications relevant to its business. The adoption of a global regulatory framework for active pharmaceutical ingredients (APIs) can only be of benefit to the licensing authorities, the industry, and – last but not least – the patient.
  • 4. Active pharmaceutical ingredients (APIs) are the constituents that give medicinal products and their pharmacological activity. For this reason, the quality and stability of APIs are crucial factors in the overall quality, safety, and efficacy of medicinal products Essentially a biological comprises, contains or is derived from human cells or human tissues and is used to treat or prevent disease, defect or injury; or diagnose the condition of a person; or influence, inhibit or modify a physiological process in persons; or test the susceptibility of persons to a disease or ailment; or replace or modify parts of the anatomy in persons. A Novel Drug or a New Molecular Entity (NME) is an active compound, a complex, molecule that previously has not been approved by the FDA/EMA. • They are still considered Novel Drugs since the extensive characterization of the pharmacological properties of that drug was carried out.
  • 5. General work profile of a Regulatory Affairs professional in an API manufacturing company  Filing a DMF/ASMF with regulatory agencies in support of the NDA / ANDA/ INDA /MAA filed by a Formulator (Drug Product manufacturer who uses API of that particular API manufacturing company).  Filing dossier of API with EDQM for obtaining CEP.  Assessing and filing amendments/variations to the information (which may be related to manufacturing, control, stability studies, etc) in DMF/ASMF/Dossier of particular API with the Regulatory agencies. Major amendments are to be reported prior to their implementation while minor amendments may be reported annually.  Taking approval of customers of API before implementing any major changes regarding the information mentioned in DMF/ASMF/Dossier. The updated DMF/ASMF may be submitted to the customer simultaneously along with amendments/variations filed with the agency
  • 6. Active Pharmaceutical Ingredient (API or drug substances) Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used so, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body .
  • 7. Regulatory Guidelines forAPIs In order to obtain marketing authorisation for a drug product the applicant has to show evidence of efficacy, safety, and quality of the drug product Different countries have different procedures for regulatory filing for API, in U.S. it has done as per the DMF procedure of the FDA while in Europe it is done by ASMF procedure. The older and off-patent APIs have an alternative assessment system called the “Certification of Suitability” (CEP). It is used in the countries that have signed the European Pharmacopoeia Convention.
  • 8. NDA  Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization  The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA
  • 9. Drug Master File or DMF A Drug Master File (DMF) is a set of documents that provides detailed information concerning facilities, protocols, and procedures used in the manufacturing, packaging, and storing of pharmaceuticals. DMF is a submission to the FDA of information, usually concerning the Chemistry, Manufacturing, and controls of a component of a drug product, to permit the FDA to review this information. Role of Drug Master Files The Drug Master File (DMF) system was developed to permit suppliers to make this information on their products directly available to FDA for its review of drug company applications that involve the use of the supplier's material.
  • 10. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a DMF is filled when two or more firms work in partnership on developing or manufacturing a drug product. The DMF should contain all the detailed information expected by the regulatory authorities so that a DMF reference in an NDA or ANDA can be used to complete an agency review process. In the United States, there is no approval process for a DMF. In fact, DMFs are only examined when referenced in other regulatory filings, such as an NDA or ANDA; then only that particular DMF with its unique reference no. is traced and reviewed. If the drug is approvable, FDA headquarters may request an inspection to be taken place at an API manufacturing site after a review of the DMF.
  • 11. Types Of DMF’s Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product Type III: Packaging Material Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation Type V: FDAAccepted Reference Information
  • 12. Requirements for Registration of API In the US active pharmaceutical ingredient is referred to as a drug substance. Registration of active substances takes place along with pre-marketing approvals like NDA & ANDA. That means there is no separate registration process for API. The manufacturer of API need to submit the information in the form of DMF. The FDA reviews the information and gives the DMF number. When the drug product manufacturer wants to get approval for the product, they mention the DMF of the drug substance as a supporting document for the applications like NDA & ANDA.
  • 13. Generally DMFs have two parts: 1. Applicant’s part: which contains non-confidential information that the license holder needs to assess for the marketing. 1. Restricted part: which contains confidential information about the manufacturing procedure that only needs to be disclosed to the authorities.
  • 14. Registration requirements of DMF: Each DMF submission should contain A. Transmittal letter B. Administrative information about the submission A. Transmittal Letters The following should be included: 1. Original Submissions 2. Amendments
  • 15. 1. Original submission: i. Identification of submission: Original, the type of DMF as classified in Section III, and its subject. ii.Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers iii.Signature of the holder or the authorized representative. iv.Typewritten name and title of the signer.
  • 16. 2. Amendments i. Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment. ii.A description of the purpose of submission, e.g. updates, revised formula, or revised process. iii.Signature of the holder or the authorized representative. iv.Typewritten name and title of the signer.
  • 17. B. Administrative Information Administrative information should include the following: 1.Original Submission 2.Amendment 1. Original Submissions a. Names and addresses of the following: i. DMF holder. ii. Corporate headquarters. iii.Manufacturing/processing facility. iv.Contact for FDA correspondence. v.Agent(s), if any.
  • 18. b. The specific responsibilities of each person are listed in any of the categories in Section a. c. Statement of commitment- A signed statement by the holder certifying that the DMF is current and that the DMF holder will comply with the statements made in it. 2. Amendments i. Name of DMF holder. ii. DMF number. iii. Name and address for correspondence. iv. Affected section and/or page numbers of the DMF. v. The name and address of each person whose IND, NDA, ANDA, DMF, or Export Application relies on the subject of the amendment for support.
  • 19. Filing of DMF  Recent update regarding USFDA DMF is now we can submit eCTD via ESG (Electronic Submission Gateway).  The deadline for the conversion of Paper format to e-CTD is beginning May 5, 2017, all submission types NDA, ANDA, BLA, and Master Files must be submitted in eCTD format.
  • 21. Biologics •Biologics are the products manufactured, extracted from, or semi-synthesized from a biological source that is regulated by FDA and are used to prevent cure and treat diseases and medical conditions. •These are generally large, complex molecules produced through biotechnology in a living system such as a microorganism, plant cell, or animal cell. •These could be made of sugars, proteins, nucleic acids, or complex combinations of these substances or may be living entities. •These are complex mixtures that are not easily identifiable and characterized these tend to be heat sensitive and susceptible to microbial contamination hence, it is necessary to use aseptic principles from the initial manufacturing process. •EXAMPLES: Botox, Herceptin, Vaccines, Enbrel
  • 22. Sources  Mammalian cell culture  Bacteria  Insect cell culture  Plant cell culture  Yeast  Transgenics  Avian cell culture  Humans
  • 23. Types  Blood derivatives  Vaccines  Allergenic extracts  Whole blood  Blood components  Proteins  Human tissues  Cellular and gene therapies  Xeno-transplantation products
  • 24. Difference b/w biologics & chemical drug Properties Biologics Chemical drug Size Large Small Structure Complex Simple Stability Unstable Stable Modification impossible to ensure identical copy identical copy made Manufacturing Many options Well defined Characterization Impossible Easy
  • 25. Biologics and its regulatory guidelines Biologic/ Biologics / biological product Biological Product is a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment, or cure of a disease or condition of human beings.
  • 26. Law orAct ▪ Drug Products fall under the Food, Drug, and Cosmetic Act. While ▪ Biological products Fall under the Food, Drug, and Cosmetic Act & Public Health Service Act
  • 27. USFDA Biologics Team The FDA biologics team was established in 1997 to assure the quality and safety of Biological products It consists of a core team of, 1. Certified ORA investigator, 2. CBER-certified inspectors, and 3. Specially trained compliance officers representing both ORAAND CBER
  • 28. Regulatory authority for biologics Centre for biologics evaluation and research (CBER) is the center within FDA that regulates biological products for human use under applicable Federal laws including the Public Health Services Act (PHS) and the Federal, Food, Drug, and Cosmetics Act CBER protects and advances public health by ensuring that biological products are safe and effective. FDA's regulatory authority for the approval of biologics resides in (PHS) Act. Biologics are subjected to regulation under the Federal, Food, Drug, And Cosmetics act (FD&C) Act. Some medical devices which are used to produce biologics are regulated by CBER under the FD&C Act’s medical device amendments of 1976.
  • 29. FDA also reviews new biological products and new indications and usage for already approved products on the market for the treatment of known diseases. It protects against threats of emerging infectious diseases. It provides the public with information to promote the safe and appropriate use of COPS DSU Department of Pharmaceutics
  • 30. Development and approval process  Advertising and Labelling  Investigational New Drug Application (IND) or Device exemption process (IDE)  Expanded Access  Premarket Approval (PMA)  Biologics License Application (BLA) New Drug Application Process (NDA).  Biologics Approvals By Year.
  • 31. Biologics license application (BLA)  The Biologics License Application (BLA) is a request for permission to introduce or deliver for introduction a Biologic product into the market.  It is mainly regulated by 21 CFR 600-800. It is submitted by any legal person or entity, who engaged in the manufacture or an applicant for a license who takes responsibility for compliance with the product and establishment of standards  A Biologic License application generally applies to vaccines and other Allergenic drug products and cellular and genetic therapies.  A cover letter should always accompany any FDA submission. Addressed below are Form FDA 356(h), the cover letter, and all 20 sections of the BLA application.  Before each section is addressed individually, it is worth emphasizing the importance of the application form [Form FDA 356(h)], the cover letter, and the first three sections.
  • 32.  Under the Public Health Services Act, the Federal Food and Drug Administration (FDA) has been given the authority, concurrent with its authority under the Food Drug and Cosmetic Act, to regulate biologics.  The FDA regulates a wide range of biologics, including vaccines, blood, and blood by-products, certain monoclonal antibodies, and tissue and cellular products.  within the FDA, the Center for Biologics as well as the Centre for Drug Evaluation and Research, can be responsible for the regulation of biologics.  Biologics are evaluated for market by the FDA through the filing of a Biologic License Application (BLA).  A BLA, although similar to a New Drug Application (NDA), has its own set of complex requirements.  Applicant has to provide the information in an acceptable format, under the applicable regulations. However, applicants must be aware that unique and specific information will be required depending on the type of BLA (e.g. – blood, vaccines).