Winter is Coming, as Well as New Regulations: Are you Ready?

November 15, 2018

 

Regulations are a part of the fabric of the pharmacovigilance industry and the pace of change is only accelerating.  Having just returned from the 2018 Foresight Argus User Group Convention in Washington DC in late October, there were several key updates that will have a profound impact on biotech firms, clinical organizations and PV companies alike.  For Drug Safety Navigator (DSN), there were 5 big takeaways that we wanted to share with you:

 

Protections for Patient/Reporter:  GDPR is Now in Effect


Launched on 25-May-2018 in Europe, the General Data Protection Regulations or GDPR are designed to protect consumer’s personally identifiable information (PII). These regulations can be difficult to interpret and the risks of non-compliance can be severe. Understanding the regulations and how they apply to the pharmacovigilance industry is a must for Pharmaceutical companies marketing products in the EU.  DSN’s TAKE:  Did you know EU Patient/Reporter PII should be masked for export, except when submitting to the EMA? DSN can help you with the complexities of EU GDPR and PII regulations and how they impact the PV Industry.  Our team can help educate you on these regulations and where the boundaries lie for protection of the public health. 

 

Electronic Reporting:  Repeat after Me – E2B & R2 R3


E2B refers to electronic submissions of pharmacovigilance/safety data to regulatory authorities, partners, affiliates, etc. via an electronic reporting gateway. R2 and R3 refer to the programmed data points, format, etc. for the profile required for these electronic submissions. R2 E2B profile is currently required for electronic reporting to the US-FDA for drugs/biologics and medical devices. There has not yet been a date set by the FDA by which they will require E2B R3 reporting for drugs and biologics. R3 E2B profile is currently required for electronic reporting to the US-FDA for vaccines, as well as all electronic submissions to the EMA (for both investigational and marketed products). DSN’s TAKE:  E2B R3 is in full effect now in Europe.  Have you considered the scope of business processes and departments that may be affected by the required change to E2B R3 electronic reporting?  This is and will continue to be a significant change in the PV Industry. The DSN team stays current on global reporting requirements and proactively plans business strategies to remain compliant and efficient.

 

Device Reporting:   Devices, Drugs & Biologics – Oh My!


“Device” refers to medical devices, such as a defibrillator or an intrathecal pump. The requirements for regulatory reporting for medical devices are quite different than those for reporting for drugs and biologics.  DSN’s TAKE:  US-FDA medical device reporting requirements were updated in July 2018 and are in effect now.  Navigating the regulations around reporting for medical devices can be confusing. DSN can help you to identify products that meet eMDR reporting requirements, and what to do with them if a device malfunction is reported. 

 

Combo Product Reporting:  When is a Combo not a Combo?


"Combination Product" refers to a product that includes components for both a drug/biologic as well as a medical device. The medical device component is often the delivery mechanism for the drug/biologic (like a pre-filled syringe). Updates to the global regulations for Combination Products is a very active arena right now and include the complexities of both medical device and drug/biologic reporting requirements. DSN’s TAKE:  New US-FDA requirements for Combo Product Reporting are scheduled to go into effect on July 31, 2019. Are you prepared for all the new guidance surrounding Drug/Device Combination Products coming in 2019-2020?  It’s not easy to identify if a product meets the definition of a Drug/Device Combination, or when and where to report the information. DSN can help you to identify products that qualify as Combo Products, implement a decision tree for reporting requirements, and determine where and when to submit the required information. 

 

Safety Signaling:  Pilot Program to Pave Way to New Regs in EU


On February 22, 2018, the EMA launched a one-year pilot program for new requirement for EU marketing authorization holders (MAHs) to review the EV Data Analysis System (EVDAS) on a regular basis for potential signals/trends identified by the EMA for their EU marketed products. Pilot program has been extended to September 2019. DSN’s TAKE:  Once the pilot is completed, we expect updated guidance to be published requiring all EU MAHs to perform signal detection in EVDAS.  We can perform the risk assessment needed to determine EVDAS Safety Signal search parameters and frequency to keep you compliant with this new requirement.

 

Still have questions?  Or would you like to discuss the impacts of these upcoming changes?  Click here to reach out to DSN!

 

 

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