Regulatory affairs in the pharmaceutical industry Flashcards
Who controls the use and regulation of medicines
- European and National LAW outline the basis of medicine regulation
- MRHA
- European Medicine Agency (EMA)
Legislation history in the UK
1925-1962
-1925- Therapeutic substance Act
+Anti-syphilis drug, Salvarsan 606 contained toxic impuritie
+Each batch of product was submitted to Medicines research
+Council for assessment fore release for marketing in UK
1956- Thalidomide
+First launched in west Germany
+Marketing and distribution rights sold to other countries e.g. USA, UK
+May 1961- lincensees reported 75-90 cases of polyneuritis then phocomelia
+Nov 1961- Withdrawn from west Germany market
+Ministry of health issued a statement that thalidomide was a major factor in causing phocomelia. IT was withdrawn from the UK market
-1962- The committee on saftey on drugs
+Voluntary agreement by the ministers of health to look at the safety of new drugs. The committee on safety of drugs consisted of scientist, physicians and pharmacist
+They checked reasonable safety
Legislation history in the UK ]
1968-
-1968- UK Medicines ACT
+Approved by the UK governmeant in 1968
+Came into force in 1971
+AIM: to assess evidence of the safety, quality, efficacy of all medicinal products (new and old)
-1965- 65/65/EC
+EEC directive to safeguard public health
-1973- UK joined the EEC
+UK required to comply with all EEC directives
+Most important ones:75/318/EC and 75/319/EC, a harmonised view of what should be in a licensed applicaiton
+I.e. physicochemical, biological, microbiological tests, toxicological and pharmacological and clinical test
-1994- UK medicines ACT update by SI 1994/3144
+Legislation to bring UK into line with Europe (Except for clinical trials, sale and supply controls, ML/WDL and advertising)
What is a medicinal Products
Any substance or article (Not being an instrument, apparatus or applicance) Manufactured, sold, supplied, imported or exported for use by being administered to human beings for a medicinal purpose
What is a medicinal purpose
1) Treating or preventing disease
2) Diagnosing disease or ascertaining the existence, degree or tentn of physiological conditions
3) Contraception
4) Inducing aanaesthesia
5) Otherwise preventing or interfering with the normal operation of physiological function
UK licensing systems
-Section 7(2)
MEDICINES ACT 1968
-Except in accordance with a license granted for the purpose of this section (Product license) no person shall in the course of business sell, suply or export any medicinal product
-SECTIOPN 8(2)
+No person shall in the course of business manufacture or assemble any medicinal product except in accordance with a license granted for the purposes of this sections
NB- there are exceptions
Exemptions from licensing
1) Pharmacist, midwives, chiropodists
2) Vitamins- classed as a food not a medicinal product
3) Import- for administraiton tp0 the person importing product (at the specific request of a doctor)
Global regulatory health authorities
- USA: FDA (food and drug administration)
- Japan: MHW (ministry of health, labour and welfare)
- Europe: EMA
- UK: MRHA
- Other European countries have there own national agencies
Criteria required for granting a product license
-Saftey (can be used in humans)
-Efficacy (has desired therapeutic effect)
-Quality (toxic impurities)
-Not considered for the granting of license- medical need or price
NB- UK has other controls beyond the simple granting of a license e,g, LocalFormularies , National Institute of Clinical Excellence (NICE)- wont get used if NICE doesn’t say its cost effective
The common technical document (CTD)
- The common technical document is set of specification for application dossier for the registration of medicines
- Designed to be used across Europe, Japan and US
- Developed by: EMA: FDA: MHW
- The CTD is maintained by the Internation Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
The structure of the CTD
Module 1 -Administrative and prescribing information (Not harmonized) Module 2 -Quality overall summary -Non-clinical overview -Non-clinical summary -Clinical overveiw and clinical summary Module 3 -Quality data Module 4 -Non-clinical study reports Module 5 -Clinical study reports
Every medicine must possess
- Label use packaging components labelling
- Summary of product characteristics (SPC)
- Patient Information Leaflet (PIL)
- User leaflet for products used by health care professionals (HCP)
What system is used to register medicine in Europe
- Mutal recognition
- Centralised
- National (pre-1/1/98)
System is used to register medicines in Europe
Mutual recognition
-MOST COMMON
Mutual recognition
- First application is made to one EC member state authority
- National Authorisation granted
- Mutual recognition of this authorisation by other concerned member states authorities
- Each member state issues an authorisation
System is used to register medicines in Europe
-Centralised
- One single application is made to the EMA
- Two member state authorities act as rapporteurs with other member state authorities
- One single European authorisation is granted by EMA
