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Biomarkets > Regulatory Affairs > Flashcards

Regulatory Affairs Flashcards

1
Q

Name some of the prominent Regulatory bodies in the world

A

FDA, EMA,TGA (Australia), HC (Canada), PMDA (Japan), ANVISA (South America), NMPA/CDE (China?)

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2
Q

What does ICH stand for, why was it conceived and what do they do?

A
  • International Conference on Harmonisation
  • To rationalise and harmonise regulation
  • They create guidelines (79 guidelines have been written and approved)
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3
Q

What are the 4 categories the iCH guidelines focus on?

A
  • Quality (chemical and pharmaceutical quality assurance)
  • Safety (pre-clinical studies)
  • Efficacy (clinical research in human subjects)
  • Multi-disciplinary (includes MedRA (medical dictionary for regulatory activities), CTD (common technical document) and development of Electronic Standards for the Transfer of Regulatory Information)
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4
Q

Why is it important that we harmonise?

A
  • We harmonise terms, expectations etc
    E.g. everyone calling Apple products by different names
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5
Q

What is meant by that the benefit-risk balance must be considered favourable/positive?

A

E.g. New painkillers HAVE to be superior than the ones already on the market. More difficult disease treatments, then it’s fine if it’s not the best –> more risk taken

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6
Q

CTD stands for

A

Common Technical Document

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7
Q

What is NOT included in the CTD

A

Module 1 - Regional administrative information, (e.g. Labelling and pharmacovigilance)

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8
Q

What does the CTD contain?

A
  • In short: the information needed for eg FDA to review the new product
  • Contains different modules (Module 2-5), think of the triangle in the slide
  • Sufficient and complete documentation and all requirements defined in the legislation complied with:
    Quality - Manufacturing and control
    Safety - preclinical safety
    Efficacy - clinical
    –> these are presented in a way that it may be regarded safe to sell the product within the applied indications
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9
Q

From where does FDA start their CTD review?

A

FDA usually starts the review from the bottom of the triangle because they require a lot more specific data from each individual patient.

The bottom of the triangle contains information about Quality, non-clinical study reports, clinical study reports

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10
Q

The authority focus is constantly shifting, what are some of the themes their focus has been on before and what is it currently on?

A

Before; drug efficacy, drug safety, overall benefit/risk

NOW: Patient focus, Digital Health, Curative Therapies

Side note: Authorities are not sure how to regulate digital health, eg gdpr

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10
Q

The authority focus is constantly shifting, what are some of the themes their focus has been on before and what is it currently on?

A

Before; drug efficacy, drug safety, overall benefit/risk

NOW: Patient focus, Digital Health, Curative Therapies

Side note: Authorities are not sure how to regulate digital health, eg gdpr

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11
Q

What is FDA known for and what about EMA?

A

FDA is the most prominent regulatory body in the globe. Sets the agenda for a lot of what is going on.

EMA leading the field - very innovative.

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12
Q

Which version of the CTD is very important for commercial people and why?

A

the layman version of the CTD, since they can only promote what is in this.

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13
Q

What is the layman version of the CTD?

A

Module 1 - Regional administrative information

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14
Q

What are the key elements of a companies RA role in drug development?

A

In Research:
- Define and clarify regulatory requirements via early engagement
- Regulatory Intelligence and landscaping

In Development:
- Evidence generation strategies & approval with target label in mind including market access perspectives
- Pro-active Agency negotiations via scientific advices

In Submission and approval:
- Obtain approval of the product with most competitive label

In Life-cycle Management:
- Label expansions including new indications
- Approval of supply capacity

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15
Q

What is the approval from health authorities called, and is is necessary when selling a drug?

A
  • MARKET APPROVAL
  • Needed to be able to sell a drug
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16
Q

Why is the Target Product Profile/Label important?

A
  • Start with the end in mind
  • The label is the outcome and conclusion of the entire product development
  • It is the most IMPORTANT part of the MA as it provides:
    1) information to physician for use of the product - important efficacy and safety information
    2) information to patients: use and side effects
    3) framework for appropriate promotion and differentiation vs competitors

–> IMPORTANT that the TPP/Label drives the trail design and development and not vice versa

17
Q

TPP stands for

A

Target Product Profile

18
Q

Why is it important to link business needs to label as early as possible?

A

1) Is driven by market value, unmet medical needs and reimbursement opportunities
2) Takes into account what is scientifically and clinically possible
3) Incorporates expected regulatory hurdles

19
Q

When you have the label as driver, you should begin with the end in mind. So what are five things to take inconsideration?

A

1) What do you want the TPP/label to say?
2) How will potential claims, key efficacy and safety information translate into a label?
3) Review available information and understand differentiation versus competition
4) Figure out what you need to do to be able to say it
5) Use ‘label as driver’ process to guide and prioritise

20
Q

What goes into Product Information (PI) and where can you find it?

A

What goes in it:
- Company Core Data Sheet
- Summary of Product Characteristics
- Carton
- Label
- Package leaflet
- Instruction for Use

Where to find it:
- FDA/EMA website
-other agency websites

21
Q

What is the purpose of PI’s?

A
  • To provide appropriate information to health care professionals and patients on the medical product, including but not limited to use of the product, storage conditions and safety information.
  • Promotion of the product should be in accordance with the information provided in the Summary of Product Characteristics
22
Q

CCDS stands for

A

Company Core Data Sheet

23
Q

What is the CCDS?

A

-It is the main/master labelling document
- Describes all relevant and scientifically documented product information–> is basically a product summary
- Owned by RA
- Originates from development data
- Reflects the company’s point of view
- Forms the basis for the labelling documents which are used by different regions of the world
- Created on the basis of a target CCDS (tCCDS) for a new product

24
Q

Who is responsible for managing the CCDS during the entire life cycle?

A

RA

25
Q

When does the development of the CCDS start?

A

As a vision at the edge between discovery and development

26
Q

What should guide the design of the clinical trials?

A

tCCDS

27
Q

Must the CCDS be supported by data?

A

YES

28
Q

Off-label is

A

A use that fails to comply with the currently approved label

29
Q

Off-label information is

A

Communication about an unapproved drug or an off-label use of an approved drug that does not constitute promotion

30
Q

Off-label promotion is

A

Communication about an unapproved drug or an off-label use of an approved drug that promotes or is designed to promote the unapproved drug/off label-use

31
Q

When is off-label considered lawful, if it is ever considered lawful?

A

OK (lawful) with Physicians decision

32
Q

When is off-label information considered lawful, if it is ever considered lawful?

A

OK (lawful) if it is not promotional

33
Q

When is off-label communication considered lawful, if it is ever considered lawful?

A

Never ok, due to different guidelines and regulations

34
Q

SmPC stands for

A

Summary of product characteristics (this is in EU, called PI in the US)

35
Q

RDP stands for

A

Regulatory Data protection

36
Q

What is RDP?

A

RDP = Data exclusivity + Market exclusivity

  • Exclusive right to benefit from data
  • Automatically in force from date of MA
  • Enforcement of RDP is the responsibility of governments
  • Term of 5-12 years varying from country to country (longer time span in EU than US)
37
Q

What does market exclusivity mean?

A

EG that generics cannot refer to the data that has market exclusivity

38
Q

Are patents and RDP the same thing?

A

NO, but they can run in parallel

39
Q

What are some of the opportunities related to RDP?

A
  1. Patent protection is not available
  2. Patent enforcement systems are inadequate
  3. Patent is proven to be invalid
  4. Patent term has been eroded by along development process

RDP is an incentive for innovation where there is little or no patent protection

40
Q

ODD stands for

A

Orphan Drug Designation

41
Q

What are the benefits of ODD?

A
  • You get market exclusivity for 7 years from the date your MA is approved
  • R&D tax credits
  • PREA Exemptions (you do not have to conduct paediatric studies in the same context as usually or even not at all)
  • User fee exemptions

Biomarkets (10 decks)

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