Legal Flash: 8 Regulations set to impact the Pharma & Biotech Industry in 2013

Niamh Madigan


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.

Good distribution practice (GDP) ensures that the level of quality determined by GMP is maintained throughout the distribution network, so that authorised medicines are distributed to retail pharmacists and others selling medicines general public without any alteration of their properties. The principles of GDP are stated in Directive 92/25/EEC.

GDP should be implemented through a quality system operated by the distributor or wholesaler of medicinal products to ensure that:
  1. The medicinal products that they distribute are authorised in accordance with European Union (EU) legislation
  2. Storage conditions are observed at all times, including during transportation
  3. Contamination from or of other products is avoided
  4. An adequate turnover of stored medicinal products takes place
  5. Products are stored in appropriately safe and secure areas
For more information, see the revised GDP guidelines of medicinal products for human use;
And really worth checking the Cold Chain IQ  One Page Global Guide to GDP Regulations.
TWO: Food and Drug Administration Safety and Innovation Act (FDASIA)
The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 and gives the FDA the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorised two programmes that encourage paediatric drug development.
The enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) stands to have significant impact on the pharmaceutical and biologics industries, the drug industry will pay an estimated $700 million to support FDA's review of drug applications for fiscal years 2013-2017. [1]

THREE: Biosimilar User Fee Act (BsUFA)
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorises FDASIA  to assess and collect fees for biosimilar biological products from October 2012 through September 2017.  

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.

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.
FOUR: Falsified Medicines Directive & The Delegated Acts 2017

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.” [3]

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. [4]
One challenge is encouraging senior stakeholders to embrace the acts and to make funding available to begin building a programme;"No company, big or small, can be in a position to sit waiting for the specific delegated acts to be released following the falsified medicines directive. The advice is to start pilots now before scaling up, instead of waiting until the last hour. There is temptation to delay doing so because of costs and uncertainty around timing," warns Christoph  Krahenbuhl, Expert at EFPIA in a recent interview with Pharma IQ. [2]
FIVE: Quality by Design (QbD)
Partial or total QbD adoption is encouraged by  the FDA and the EMA. However, a recent study conducted by Pharma IQ, revealed that while 80% of respondents are keen to invest in QbD solutions, just over half are in the early stages of bringing this into their business [5]. Added to this, it is widely believed that QbD will become mandatory in the innovative pharma industry as it has done with the generics.

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
The guidances cover different areas as stated below:
  • Q8 (R2) Pharmaceutical Development
  • Q9 Quality Risk Management
  • Q10 Pharmaceutical Quality System

: Good Manufacturing Practice (GmP)

In January 2013, the European Commission launched the public consultation of the following revised guidelines on good manufacturing practices [6]:

  1. Chapter 3 Premises and Equipment
  2. Chapter 5 Production
  3. Chapter 6 Quality Control
  4. 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:

        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.

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.” [8]


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With special  thanks to regulatory advice from Headley Rees, PharmaFlow - and Ian Holloway, Senior Gmp Inspector at the MHRA.

[1] Life Science Leader:
[2] Ensure Manufacturing Readiness: Practical Mistakes to Prepare for the Delegated Acts: Podcast with  Christoph  Krahenbuhl, Expert at EFPIA
[3] The Falsified Medicines Directive, MHRA,
[4] EU Falsified Medicines Directive;
[5] Changes in PAT and QbD Investment and Implementation: 2010-2012;
[6] Good Manufacturing Process (GmP):
[8] Good Manufacturing Process for APIs - Countdown to 2013: the EU gets tough on imported APIs: