Legal Flash: 8 Regulations set to impact the Pharma & Biotech Industry in 2013
Pharma IQ has put together a list of 8 regulations and guidelines that look set to impact different divisions of the biotech and pharma industry in 2013.
ONE: Good Distribution Practice (GDP) 2013
The revised European Commission Guidelines on the distribution of medicinal products in the EU will come into force in September 2013.
GDP should be implemented through a quality system operated by the distributor or wholesaler of medicinal products to ensure that:
- The medicinal products that they distribute are authorised in accordance with European Union (EU) legislation
- Storage conditions are observed at all times, including during transportation
- Contamination from or of other products is avoided
- An adequate turnover of stored medicinal products takes place
- Products are stored in appropriately safe and secure areas
And really worth checking the Cold Chain IQ One Page Global Guide to GDP Regulations.
For more information on the Act: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/
THREE: Biosimilar User Fee Act (BsUFA)
FDA dedicates these fees to expediting the review process for biosimilar biological products. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient. http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/default.htm
There has been some mixed reaction to this collection of fees. “This new fee payment schedule could impact the timing for initiation of the development process and cause companies to delay contacting FDA until adequate and sustainable revenues are available. The payments could also affect the triggering of payment milestones in licensing transactions and the timing of venture capital investment in biosimilar companies,” says US Legal firm Morgan Lewis.
The Falsified Medicines Directive (FMD) 2011/62/EU was passed in 2011 and adopted internationally. This Act was aimed at reducing the number of falsified medicines which were entering the supply chain.
The MHRA explains; “The 2011 Directive lays down the rules for manufacturing, importing, placing on the market, and the wholesale distribution of medicinal products in the European Union as well as rules relating to active substances and certain excipients.” 
The Delegated Acts which are due in 2014 and likely to come into force in 2017, will flesh out the details of this directive. These Acts will implement the decision around unique serial number specifications and set out details for a verification system, with full compliance across Europe by 2017. 
ICH Q8/Q9/Q10: The International Conference on Harmonisation (ICH) prepared three important guidance documents related to the development and implementation of PAT and QbD into a regulated environment in 2011 in an attempt to harmonise regulations globally. These documents form the basis of the ICH Q8/Q9/Q10
- Q8 (R2) Pharmaceutical Development
- Q9 Quality Risk Management
- Q10 Pharmaceutical Quality System
SIX: Good Manufacturing Practice (GmP)
In January 2013, the European Commission launched the public consultation of the following revised guidelines on good manufacturing practices :
- Chapter 3 Premises and Equipment
- Chapter 5 Production
- Chapter 6 Quality Control
- Chapter 8 Complaints, Quality Defects and Product Recall
Comments and suggestions are invited by 18 July 2013.
SEVEN: Good Manufacturing Practice for APIs
The Falsified Medicines Directive introduces a number of requirements aimed at strengthening the supply chain for medicinal products. This may lead to EU-specific requirements relating to Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (API).
API importation controls are expected to be announced in July 2013, whereby APIs imported into the EU must comply with the good manufacturing practice (GMP) standards used by the EU, as stipulated by the International Conference for Harmonisation (ICH Q7). However, there appears to be some uncertainty about the steps that need to be taken. More Information: http://ec.europa.eu/health/human-use/quality/developements/index_en.htm
EIGHT: Pharmacovigilance legislation
The EMA welcomes the start of new European Union (EU) legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF
The Agency’s Executive Director Guido Rasi explains, “The new pharmacovigilance legislation will help us to make the system more robust for public health and more transparent. It gives regulators a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines. It also increases the efficiency of medicines regulation for the benefit of all stakeholders.” 
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 Ensure Manufacturing Readiness: Practical Mistakes to Prepare for the Delegated Acts: Podcast with Christoph Krahenbuhl, Expert at EFPIA http://www.pharma-iq.com/logistics/podcasts/ensure-manufacturing-readiness-practical-steps-to/
 The Falsified Medicines Directive, MHRA, http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON213167
 EU Falsified Medicines Directive; http://www.lilly-europe.eu/img/PDF/FMD-infograph.pdf
 Changes in PAT and QbD Investment and Implementation: 2010-2012; http://www.pharma-iq.com/manufacturing/white-papers/changes-in-pat-and-qbd-investment-and-implementati/
 Good Manufacturing Process (GmP): http://ec.europa.eu/health/human-use/quality/developements/index_en.htm
 Good Manufacturing Process for APIs - Countdown to 2013: the EU gets tough on imported APIs: