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Drug Regulatory Affairs


Drug Regulatory Affairs Institute of Drug Regulatory Affairs Faculty of Pharmacy University of Szeged * Regulated and standardised fields For what they apply? – PowerPoint PPT presentation

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Title: Drug Regulatory Affairs

Drug Regulatory Affairs
  • Institute of Drug Regulatory Affairs
  • Faculty of Pharmacy
  • University of Szeged

  • Tamás L. Paál, Professor
  • for 23 years Head of the Hungarian national
    competent drug (human) regulatory authority
  • now retired, but President of the Scientific
    Board of the same authority
  • Also President of the Hungarian
  • World Health Organization (WHO) expert (quality
    assurance, drug regulatory affairs, herbal
    medicines, drug side effect signal assessment)
  • Drug Regulatory Affair field project expertise
    (WHO or EU) Nicaragua, Uganda, Uzbekistan,
    Kazakhstan, Turkmenistan, Bosnia and Herzegovina
  • Officially visited 58 countries until now

Where are you from?
Technical details
  • The slides of the lectures will appear on the
    University LAN
  • www.pharm.u-szeged.hu/gyfi/GyIgaz
  • They are detailed enough to learn
  • However, students are expected to attend the
    lectures, otherwise it is extremely difficult

Do not know!
The files starting with W!
Blood droplets
Exam topics
  • will be presented at the end of any lecture topic
  • Not only topic titles! The Students will be
    provided also with the bullet points (subtopics
    they should deal with)
  • An example is provided on the next slide
  • As a rule, the exam covers 3-4 topics

Example for the exam topics
  • Basic elements of law
  • Speak about the definitions in a law, then
    discuss the following
  • law
  • law-maker (discuss various possibilities in
    different countries)
  • law enforcing bodies/persons (name some of them)
  • sources of law (both meanings)
  • different pieces of law. as a rule, the type of
    their content, their hierarchy, where are they
  • what is soft law
  • what is co-authority
  • quasi authorities (what is the rigth for

Warning, 1
  • In my lectures
  • drug
  • drug product
  • medicine
  • medicinal product
  • pharmaceutical (product)
  • are used as synonyms! (As a rule, drug appears
    on the slide for it is the shortest word!)

Warning, 2
  • In my lectures
  • drug, drug product, medicine, medicinal product,
    pharmaceutical (product)
  • means the one that is ready to take by or
    administered to humans! ( Dosage-forms)
  • When I speak about drug substances, I use the
    term active pharmaceutical ingredient (API)

  • (English is a funny language and different
    countries and organisations use different
    terminologies, sometimes deliberately)
  • E.g.
  • Drug medicinal product
  • pharmaceutical product

former EFTA
Drug Regulatory Affairs
What the hell they are?
Drug regulatory affairs
  • Thus, what (the hell) they are?
  • In some Universities part of Pharmacy
    Administration - is it right? To administer it
    or to know it?
  • Better approach what knowledge is needed for a
    graduate pharmacist? (Who may work anywhere from
    a community pharmacy to drug research)
  • An answer has been given by the European Union!
    see later!

Drug regulatory affairs
  • Any activity with drugs

no (does not belong to drug regulatory affairs)
Prior authorisation needed?
By whom? (the authority)
Based on which (objective and subjective)
Subject to regular control (quality, inspection)?
Based on which (objective and subjective)
By whom? (the authority)
Activities with drugs
  • research (chemical, biological)
  • clinical trials on human beings
  • manufacture
  • registration
  • evaluation
  • authorisation
  • (wholesale) distribution

Activities with drugs (contd)
  • (retail) distribution
  • pricing
  • prescribing
  • reimbursement/subsidy
  • advertising (if any)
  • special control (e.g. narcotics)
  • post-marketing surveillance
  • national drug quality control lab
  • adverse effect reporting system
  • etc.

Where to find regulations?
  • The so called hard law (Acts of Parliament,
    Governmental and Ministerial Decrees, etc.)
  • The so called soft law (guidelines,
    methodological letters, etc. showing how
    competent authorities understand and use the hard
  • To some extent, also codes of conduct
    (professional and ethical ones)
  • It will be discussed in detail later!

What to teach?
  • It is so simple for, e.g. chemistry and
    technology they are the same everywhere (law
  • It is also simple for the Hungarian
    undergraduates the topic is the Hungarian/EU
    regulatory affairs
  • But you have come from (and return to) different
    countries with equally different drug regulatory

Principles of this course
  • Teaching World Health Organization (WHO) advised
    rules, they are universal
  • Always call the attention of the students to
    that is what you should clarify when returning
  • Show European Union (EU) and Hungarian rules as
    examples only

Regulatory affairs
  • Our life is regulated in many different ways

Rules governing our life
hard law
custom/fashion, common courtesy
Ethical rules
professional rules
Rules governing our life
  • Costum/fashion, common courtesy not always
    written, varies with the cultures greeting, (not)
    taking mans hat off, cutlery, rolls
    left-hand-side but maybe serious position of
    children/women is certain cultures
  • Ethical rules in a given professional circle
    mainly written partly sanctioned you are
    expected to do this Ethical Codes of
    Professional Chambers, of Industry Associations
    (e.g. on medical advertising), Helsinki
    Declaration of Physicians otherwise you are not
    accepted in the Golf Club
  • contd

Rules governing our life Contd
  • Rules of the profession (soft law) as a rule
    written this professional (e.g. pharmacist) is
    expected to do this (in a given situation) in
    case, the Court tends to follow it in its
  • (Hard) Law enforceable! Negative authority
    decisions, police measures, Courts judgement

Hierarchy of the rules
(hard) law
Professi-onal rules (soft law)
Ethical rules
Custom, fashion, common courtesy
Hierarchy of the most important professional
rules in Hungary
  • Hard law
  • Soft law
  • Constitution
  • Acts of Parliament
  • Governmental Decree
  • Ministers Decree
  • (Municipality Decree)
  • ministerial guidelines
  • methodological letters of
  • National Boards/Institutes
  • scientific literature

Are there other rules in your country?
  • Presidential Decree?
  • Royal Decree?
  • Common (precedent) law?
  • Any other type of soft law?

Presidential rules
  • Countries vary!
  • strong president (USA, Germany head of the
    executive power)
  • weak president only ceremonies, limited rights
    to interfere (e.g. decision on the date of the
    elections, etc., many European countries)
  • In between (e.g. France)
  • Hidden presidential ruling (e.g. in former Soviet
    Central Asia)

Royal ruling
  • In some countries traditional, instead of State
    president (dinasties versus elected presidents).
  • weak (only ceremonies)
  • strong (admitted or hidden ruling)

Common law
  • Anglo-saxoon system the precedent is binding
  • If a Court delivered a decision in a case
  • another (same level) Court
  • in a similar case
  • must deliver the same decision!
  • Thus, Court decisions are taken as law (common

Any other rules governing drug affairs in your
Drug regulatory affairs
  • Can be taught in various ways...

Simply the content of the rule
As for law graduates...
Everybody knows the football game (at least in
Hungary) (except the national coach!)
  • Imagine a very good football player
  • His only problem is that he does not know the
    rules e.g. hands-off, offside, etc.
  • What is your opinion, can he be successful as a
    team member?

The same is valid for Drug Regulatory Affairs!
  • It is more than simple administration!
  • The Art of Pharmacy belongs to the Regulated
    Field! Thus, to know the relevant regulations is
    the professional life itself!
  • This is the topic you must know, if anything!
  • The problem is you can not simply learn it, the
    rather because the details may be different in
    your homelands! Instead, you must understand the
    logic behind it!
  • This is when I try to help you!

You may think you are experienced already. Is it
  • Who is law-maker? Who is enforcing the law?
  • Is a pamphlet of a drug wholesaler, describing
    regulations a source or interpretation of the
    law/regulations? (Must you obey it?)
  • What is co-authority? e.g. corresponding
  • What is the answer to the question why so many
    similar drug products are registered?
  • What to do, when a patient
  • - makes a complaint in the pharmacy?
  • - brings the medicine back, for, according to
    him/her, it had no efficacy?

Do you know the right answer?
  • It is not very probable, although they were so
    simple questions
  • At the end of this semester, however, not only
    these but much more difficult questions can be
    answered, and what is more

you will know, what to do!
Thus, this is not law or theory but how the
Pharmacy affairs (in their broadest meaning) are
It is true...
  • Knowing is not enough, we must apply!
  • Willing is not enough, we must do!
  • Goethe

Medicines regulatory affairs
  • It is by no means boring! It has interesting
    stories and an inherent logic
  • It can be taught very boring, but it is not the
    fault of the regulatory affairs...

Why do we teach regulatory affairs
  • for pharmacy undergraduates?
  • The best answer is given by the European Union!

Thus what is the guidance of the European Union
for the pharmacy undergraduate curricula?
The 85/432/EEC Council Directive...
  • concerning the coordination of provisions laid
    down by Law, Regulation or Administrative Action
    in respect of certain activities in the field of
  • Article 2 summarises in seven paragraphs what
    should be covered during the under-graduate
    courses (not listing the disciplines, rather
    stressing their content)

The training shall ensure adequate knowledge of
  1. medicines and substances used in their
  2. pharm. technology and physical, chemical,
    (micro)biological testing of medicines
  3. effect, metabolism and proper use of medicines,
    action of toxic substances
  4. evaluation of scientific knowledge concerning
    medicines (to supply appropriate info on them)
  5. legal and other requirements of the practice of

Let us have a closer look
The training shall ensure adequate knowledge of
  1. medicines and substances used in their
  2. pharm. technology and physical, chemical,
    (micro)biological testing of medicines
  3. effect, metabolism and proper use of medicines,
    action of toxic substances
  4. evaluation of scientific knowledge concerning
    medicines (to supply appropriate info on them)
  5. legal and other requirements of the practice of

clear-cut Drug Regulatory Affairs!
partly belong to Drug Regulatory Affairs (drug
assessment for registration)!
New Chapter Why is the knowledge of rules so
important in the field of Drug affairs?

Regulated and standardised fields
  • Two distinct fields of products and services can
    be identified. They can well be distinguished
    although, in the real World, they may be

Standard? Regulation?
  • Standardised field
  • Regulated by the market
  • based on Standards (e.g. ISO)
  • Agreements
  • Accreditation (by non-profit) and certification
    (by private for-profit bodies)
  • Regulated field
  • Regulated by authorities
  • based on Laws, Pharmacopoeia
  • Authorisation, registration
  • Certification by authorities

Standards (e.g. ISO) as a rule, only an
agreement of the stakeholders in the market...
  • 110 V 220

AC voltage
Receptacles (sockets)
Written national
  • standards are elaborated by non-profit bodies,
    appointed from the stakeholders (both
    governmental and the interested manufacturers)
  • agreement of the stakeholders on the market
  • as a rule, based on existing International
    Standardisation Organisation (ISO) standards

  • as a rule, are not binding
  • (only express the interest of the majority of the
    stakeholders, if you ignore it can not sell your
  • may be taken mandatory by a law (the law-maker
    needs rules, there is a standard, instead of
    elaborating similar rules refers to the standard
    the standard becomes law)
  • In some countries every standard is at the level
    of law (former Soviet Union!)

Thus, misunderstanding...
  • the Pharmacopoeia is the standard of the quality
    of medicines
  • Standard (set of requirements), but not in the
    ISO meaning...
  • the word standard has broader and narrower
    meanings in English

New Chapter How drug affairs have been placed on
the regulated field?
Some history of Drug Regulation (WHO)
  • Drugs are special commodity, there have been
    always concerns about their quality regulated
    control (regulated field!)
  • Ancient Egypt in the 1st century BC written laws
    regulated physicians how to treat patients with
    drugs punishment
  • 1st century AD written methods to combat drug
  • Medieval times in Muslim countries preparation
    of medicines inspected by the Muhtasib (an
    official supervising also bazaars, schools, etc.)

Some history of Drug Regulation
  • Europe, 11th-12th Century laws on doctors
    forbidden to enter into common business with
  • In the UK a law passed in 1540 apothecaries to
    be inspected for drugs that were defective,
    corrupted or not convenient to be administered
    for the health of mans body

Some history of Drug Regulation
  • And from the late 19th Century industrial drug
    production, trade gross adulteration possible
    social pressure for regulation and control (
    regulated field)
  • To-day proliferation of products, manufacturers,
    suppliers, promotion activities, also drugs with
    serious side effects (the thalidomide affair
    fetal deformities), etc. even more pressure and
    more developed regulation

Should we know it? A little WHO statistics
  • from 6 WHO member states
  • 1 has well-developed drug regulation
  • 3 have some
  • 2 have no Drug Regulatory Authority but limited
    capacities that hardly can function

Further arguments for drug regulation, 1
  • Many interested intermediaries
  • In ancient times the competent healer (also
    producing medicines) the patient
  • To-day researchers, manufacturers, distributors,
    promoters and medical sales representatives,
    private insurers, dispensers variety of third
    party interactions

Further arguments for drug regulation, 2
  • Information
  • Drugs are not selected by patients but mostly
    prescribed by physicians, who depend mostly on
    manufacturers/sellers information. In
    unregulated markets this info were completely
    influenced by profit motives

Further arguments for drug regulation, 3
  • Financial considerations
  • If there are no or inadequate rules, the
    prescriber is completely nonsensitive to
    treatment expenses resources wasted (it may also
    happen if the drug costs are totally paid by the
  • If pharmacists income is simply linked to the
    price of non-prescription drugs sold financial
    interest to advise the more expensive one

Further arguments for drug regulation, 4
  • Drug testing and outcomes
  • For registration, drug manufacturers are required
    to perform various (incl. animal) studies to
    demonstrate therapeutic benefits. If no such
    regulation exists, expensive or lengthy studies
    were omitted that would give rise to marketing of
    drugs of poor safety and/or efficacy (but with
    higher profit)

Further arguments for drug regulation, 5
  • Misuse of drugs and drug shortages
  • They may have serious impact on the health of
    both the individual and the entire population.
  • Example antibiotic misuse (low or not enough
    doses, e.g. for shortages) ? microbial resistance
    ? other patients in danger
  • Example curing a communicable disease patients
    prevents further transmissions

Further arguments for drug regulation, 6
  • Storage
  • Drugs have limited shelf-life. Improper storage
    deteriorates them rapidly. Consequences
  • no (decreased) therapeutic value
  • even toxic degradation products

Newer arguments for drug regulation
  • New phenomenon counterfeit medicines
  • Imitating a marketed product, but
  • with no active ingredient at all
  • with decreased active ingredient content
  • with a purer quality (content, bioavailability)
  • sometimes simply using the reputation of another
    Firms medicines

Regulatory affairs and the National Drug Policy
What is the content of Drug Regulatory Affairs?
  • According to WHO, it is part of the National Drug
  • Why a Drug Policy?
  • Practically in all countries (from the Third
    World to USA), problems
  • ensuring availability of safe, efficacious and
    good quality drugs to the whole population (
    affordability and/or distribution),
  • rational drug use

Components of the Drug Policy
  • Legislation, regulations and guidelines
  • Selection of drugs
  • Supply
  • Pharmaceutical Quality Assurance
  • Rational use of drugs
  • Economic strategies for drugs
  • Research
  • Human resources development
  • Monitoring of the drug policy

Drug Regulatory Affairs themselves / hard and
soft law on
Components of Drug Regulatory Affairs, 1
  • Research on animals - ?
  • human
    clinical trials
  • Manufacture authorised? Local healers?
  • Registration assessed or simply registered?
  • Procurement State? Public service obligation?
  • Distribution wholesale

  • community pharmacies
  • hospital
  • doctors
  • other

Components of Drug Regulatory Affairs, 2
  • Narcotic drugs
  • Psychotropic substances
  • Precursor substances
  • Regulatory control
  • national lab?
  • quality defect reporting?
  • ADR monitoring?
  • inspections?

Components of Drug Regulatory Affairs, 3
  • Product service liability
  • Patients rights
  • Drug advertising/promotion
  • for health
  • for the
    general public
  • Prescribing rules
  • Wasting drugs
  • Professional Chambers, Societies

Components of Drug Regulatory Affairs, 4
  • Pricing, reimbursement/subsidy
  • In relation to that

Getting started (Maybe, some repetition from the
last Basic law Semester, but it is important)
Getting started certain fundamental conceptions
  • Law statutory regulation
  • Law-maker corporate body or person authorised to
    issue a piece of law
  • Person applying/enforcing law an official who,
    on the basis of law, may make (civil service)

Law-maker, 1
  • You must consult the legal system in your
  • Is it a Federal country? If yes, what legislative
    tasks have the lands (territories?) What is
    covered by the Federal and what by the Lands
  • E.g. medicines registration is federal in the USA
    and Switzerland, semi-federal in Germany

Law-maker, 2
  • Do you have Republic, Kingdom, etc.?
  • If Parliamentary Republic, are there two Houses?
    E.g. House of Common and House of Lords in the
    UK, Congress and Senate in the USA
  • Any law-making power of the former?

Typical law-makers
  • (President of the State/King?)
  • Parliament
  • Prime Minister/Government
  • Minister
  • (Other National Body)
  • Municipalities - the Body?

Law-enforcement organs
  • (Head of an) Authority or his/her authorised
  • Part of the Ministry or independent Agency?
  • (Head of) another Body, authorised for certain
    law-enforcement tasks
  • Judge (Court, Jury)
  • (Municipality) clerk

Plus one further issue
  • What law-making/enforcing authorisation for the
    President of State or the King in your country?
  • more Presidential systems USA, BRD, France
  • less Presidential UK (the king or queen), many
    European countries

In certain countries (like Hungary), the
law-enforcement authority is given...
  • to single persons! (Even if more such persons
    are acting!)
  • Thus, civil service law-enforcement is bound to
    authorised persons here!

Pieces of law 1
  • Sources of law (two meanings both the law-maker
    and where the law is published)
  • Parliament
  • Government
  • Minister
  • (Municipality, President, King)

Pieces of law 2
  • You should identify what kind of pieces of law do
    and did exist (some outdated forms might remain
    in force)
  • Soft law e.g. guidelines, methodological
    letters, etc. of authorities or professional
    Bodies NOT pieces of law!

Typical pieces of law
  • Act of Parliament (Bill before)
  • Created by the Parliament According to its
    accepted plans. Modification is this Act open
    for it?
  • What is contained in an Act? What concerns every
  • Signed by e.g. President of the Parliament and
    State President or King (why! Veto for one
    occasion, or this right for the Senate etc.)

Typical pieces of law 2
  • Decree of a Minister
  • Created by the Minister (Ministry?) When as a
    rule when an Act gives the authorisation for it!
    (In general or concrete)
  • What is contained? What concerns the
    professionals in the given field under the
    supervision of that Ministry
  • Signed by the Minister

Typical pieces of law 3
  • Governmental Decree
  • Created by the Government when an Act gives the
    authorisation for it! (In general or concrete)
  • What is contained? What relates professionals
    working under the supervision of various
  • Signed by the Prime Minister

Examples in what pieces of law to specify
certain rules
  • Hungarian Health-care Act (e.g. human clinical
    trials only informed volunteers, consent can be
    withdrawn any tim, etc.)
  • Hungarian Decree of the Minister of Health on
    Clinical Trials (e.g. which authority to approve,
    which Ethical Committee competent, what is to be
    assessed for approval, etc.)

Hierarchy of the pieces of law
  • The inferior may not contradict the superior
    (e.g. may not modify it)
  • Act gt Govnmental Decree gt Minist. Decree
  • E.g. if the definition of medicine is specified
    in an Act, the Health Minister may not issue an
    overlapping definition to nutraceuticals (food
    for special dietary needs) in a Decree...

Where are pieces of law proclaimed
  • Official Gazettes of the State Acts,
    Governmental Decrees
  • Official Gazettes of a given Ministry
    Ministerial Decrees important! If such pieces of
    law relate Pharmacy affairs, these Gazetts should
    be available for the pharmacies. Is there any
    rule for their mandatory subscription?
  • Is, e.g. an updated law-collection available on

Soft law state-of-art rules of the profession
  • Guidelines, methodological letters of Ministries,
    National Institutes, Boards
  • Lawyers attitude not binding - true but do
    not deviate from them without a good reason! For
  • some of them details the law
  • piece of law refers to some of them
  • their meaning is it is acceptable this way (you
    may deviate from it if the result is the same) -
    the majority do not want to litigate but wants to
    know the right solution...

Public Authorities, other Institutions authorized
with such tasks, co-authorities
  • It is extremely difficult to understand for many
  • Any authority (authoritative task) may be given
    by a piece of law, detailing the
  • Public/Regulatory Authority, Civil Service
    Agency, etc. synonyms but the name may vary from
    country to country

Public Authority
  • As a rule, appointed by an Act to execute
    regulatory tasks (almost) exclusively
  • Ministries, Police, Municipality staff, Customs
    officers, Public Health Service officers
  • Other name of the Organisation Office for...

Other institutions with authoritative tasks
  • Principally (e.g. specified in their Foundation
    Document) not authorities
  • As a rule, supervised by the Government or a
  • A piece of law delegates given authoritative
    functions to them

A Hungarian example for delegation of
authoritative functions
  • National Institute of Pharmacy - its Foundation
  • in the field of Pharmacy, it is the
    organisational-methodological-scientific and
    postgraduate teaching institution of the Ministry
    of Health
  • plus it fulfils the authoritative functions
    delegated by pieces of law

  • NOT some sort of an inferior authority!
  • When more then one authorities are concerned in
    one single civil service procedure, one is
    appointed (by law) as the authority (to issue
    the decision) while the others are named (in this
    procedure) co-authorities!

  • Hungarian example
  • Supervision of advertising of non-prescription
    medicines to health-care professionals
  • The authority is the Ofice for Health Insurance
    Supervision, with the National Institute of
    Pharmacy as professional co-authority

What is (as a rule) the responsibility of the
  • If it approves, the authority still may refuse
    the application (on the basis of its own opinion,
    without prejudice of the co-authoritys), but
  • if the co-authority has a negative opinion the
    application must be refused (Veto!)
  • The co-authoritys opinion, on its professional
    field, must be accepted (it has even right for an

Quasi right for veto
  • An organ, not appointed as authority (often Trade
    Union or Chamber) has the right for agreement
    according to a piece of law. If it does not
    agree, the process is stopped (the regulation
    will not come into force, etc.). As written in
    the piece of law
  • The (authority) authorises the with the
    agreement of XY

Right for expressing the opinion
  • The (authority) may authorise the after
    asking for the opinion (or knowing the opinion)
    of XY
  • It means that the opinion must be asked for but
    it should not obeyed

Other discussions before issuing a law
  • E.g. opinion of professional Societies or
    Chambers or Associations ought to be requested
    for, but it is not obligatory and the opinion is
    by no means binding

Exam topics!
Regulated and standardised fields
  • For what they apply? (2)
  • Explain their 4 main differences (with examples)
  • To which field drugs regulatory affairs belong to
    and why?

Basic elements of law
  • Speak about the definitions in a law, then
    discuss the following
  • law
  • law-maker (discuss various possibilities in
    different countries)
  • law enforcing bodies/persons (name some of them)
  • sources of law (both meanings)
  • different pieces of law. as a rule, the type of
    their content, their hierarchy, where are they
  • what is soft law
  • what is co-authority
  • quasi authorities (what is the rigth for

O.K., let us change the topic now
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