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Regulatory Issues US and Abroad. BIT 230 Chapters 9-11 Huxsoll. Regulatory Affairs. Separate discipline that is part of product development team Know laws enforced by FDA Certain area of FDA presides over your product

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regulatory issues us and abroad

Regulatory IssuesUS and Abroad

BIT 230

Chapters 9-11 Huxsoll

regulatory affairs
Regulatory Affairs
  • Separate discipline that is part of product development team
  • Know laws enforced by FDA
  • Certain area of FDA presides over your product
  • Liaison between company and government - CSO (Consumer Safety Officer)- point person from FDA
  • Review - law enforcement agency charged with the health and safety of food, drugs, cosmetics, medical devices
  • Division
    • CDER - drugs
    • CBER - biologics
    • CDRH - devices/radiologic health
    • CVM - veterinary medicine
    • CFSAN - food safety and applied nutrition
  • SAFETY and efficacy
  • Burden of proof for safety and efficacy evidence from product sponsor
  • FDA decides if there is enough evidence to approve product
  • needs ‘substantial evidence” (between preponderance of evidence and beyond a reasonable doubt)
  • rules often reactive to a crisis
fda activities
FDA activities
  • Rulemaking - formulating, amending or repealing a rule
    • disseminating info. To public
  • Adjudication - agency process for the formulation of an order (telling someone what to do
    • responds to sponsor’s application for approval to the FDA
guidelines points to consider
Guidelines & Points to Consider
  • Guidelines - procedures and standards acceptable to the FDA
    • communicate info that FDA has vast experience
  • Points to Consider -
    • areas where FDA has little experience
  • Guidelines and PtC not enforceable requirements (like other aspects of FDA)
product characterization
Product Characterization
  • See pages 142-143 -product definitions
  • Drug
    • cure, diagnose, treat prevent
  • Device
    • instrument, apparatus, machine, implant, reagent
  • Biological product
    • virus, serum, toxin, vaccine, blood product
regulatory functions
Regulatory functions
  • Submissions
  • Compliance
  • Enforcement
  • Miscellaneous
  • File application with the FDA
  • NDA - new drug application - product not yet recognized as safe and effective
  • Devices - Class O, II, III; I and II need a Premarket Notification- 90 day notice before goes into market; Class III needs FDA approval before commercial marketing begins
submission cont d
Submission cont’d
  • Biological products - requirements special
  • PLA - product license application, to describe the product
  • ELA - establishment license application -to describe the facilities used to manufacture the product
submission cont d1
Submission cont’d
  • Remember three areas:
    • premarketing (IND)
    • marketing (NDA)
    • postmarketing (after on the market)
  • GLP
    • nonclinical laboratory studies
  • GMP
    • set of rules for drugs, medical devices and biologics
  • GCP
    • inform subjects of test product in clinical trials
other compliance areas
Other compliance areas
  • Study/data audits
    • review raw data in reports
  • corporate policies and procedures
    • self-imposed procedures for compliance
  • submissions commitments
    • especially to coordinate manufacturing facilities in different countries
  • 3 key points:
    • documentation
    • documentation
    • documentation
  • Civil or criminal penalties
  • Product liability suits
  • From Huxsoll page 147:
    • “ Enforcement is the end result of a lack of integration. It implies a failure in the systems designated to prevent mistakes and inadvertent or untested changes.”
  • State requirements for compliance (in addition to federal)
  • e.g in book- California State Board of Pharmacy says pharmacist responsible for manufacturing
  • State and federal laws for controlled substances
  • Incentives for orphan products
one europe
One Europe
  • 1995 “mutual regulation” for drug regulation by EU members
  • European Medicines Evaluation Agency (EMEA) - administering centralized procedure
  • Submit to agency and can get simultaneous approval in many European countries (for highly innovative products)
other products
Other Products
  • Conventional products - submit filing to country of choice
  • Once approved there, other members of the EU will recognize the drug’s registration
  • Send to central agency only if concerns about original registration in Europe
european drug market
European Drug Market
  • Small continent in comparison to some others, but one of largest drug markets outside the US (total population of Europe estimated at 400 million, down from # in textbook of close to 700 million)
  • Uses many medicines
  • Approval may be faster in Europe
  • RU 486 example
  • 1957 European Economic Community
  • France, Germany, Belgium, Italy, Luxembourg and Netherlands
  • Formed to achieve harmonization of laws and regulations for bringing drugs to market
special organizations
Special organizations
  • Concertation procedure, for marketing products
    • Recombinant DNA products
    • transformed lines
    • hybridoma and monoclonal antibody procedures
    • Referred to the CPMP (Committee for Proprietary Medicinal Products)
  • Europe faster approval time lines than US (although not much; 417 vs. 452 days for US
  • For recombinant products, 411 in Europe vs. 548 days for approval in US’
  • FDA faster than EMEA on monoclonal antibody approval
approvals cont d
Approvals cont’d
  • EMEA doesn’t have priority review like FDA does; may try and implement such a review
  • See and review handout from Tufts about EU/EMEA summary
the ministry of health welfare
The Ministry of Health & Welfare
  • Oversees social welfare, social security and public health in Japan
  • Made up of several bureaus, local branches and affiliations
  • PAB(Pharmaceutical Affairs Bureau) one of bureau for drugs
  • Page 174 - chart (DO NOT need to know!)
  • Supervises domestic & foreign drug-related products
  • Director General of the PAB similar to head of FDA
  • 8 divisions within PAB to deal with various aspects (biologics & antibiotics, safety, etc.)
  • Many functions similar to US (fee page 175)
  • Central Pharmaceutical Affairs Council
  • Powerful agency within ministry
  • Government advisory committee
  • Makes recommendation for final approval for drug manufacturing and importation of foreign drugs
standards for production
Standards for Production
  • Japan has GLP, GMP and GCP regulations
  • for GCP, has guidelines for 14 therapeutic areas (page 177- DO NOT need to know)
  • Some bilateral agreements with countries to ensure quality
  • Several agencies within Japan work together develop guidelines
drug registration
Drug Registration
  • Before 1983, formal partnership was needed with a Japanese country
  • 1983 amendment, foreign drug producers can apply directly to import and sell drugs in Japan
  • Japan (along with Europe) prescribe our drugs
  • See page 181
  • Cell culture, Seed cell lines, MCB and Cell banks - similar definitions to the US terminology
  • CPAC says biologics should be considered entirely new drugs - must undergo complete preclinical and clinical testing again.
manufacturing criteria
Manufacturing Criteria
  • Define origin and characteristics of seed cell line
  • Define method of prep, storage and maintenance of MCB
  • QA issues
  • Stability of cells being used
clinical studies
Clinical Studies
  • Japan uses Phase I, II, and III testing
  • Same as ours:
    • Phase 1: pharmacokinetics in healthy patients
    • Phase II: small group with disease to look at efficacy and continue looking at safety
    • Phase III: larger group of patients with disease to look at efficacy
  • Parallels drug approval process of FDA in US
  • Canadian drug approval