3 min read
Applicants often misunderstand the scope of the meetings with the Medicines and Healthcare products Regulatory Agency (MHRA) and fail to comply with the legislative requirements of such meetings. These misunderstandings create prejudice against the procedure and affect the success rate of the meetings.
Scientific advice meetings with the MHRA can be held in the following phases.
- At any stage of the initial product development
- Before submission of the application for Marketing Authorization (MA)
- During the pre-submission period for a variation to the existing MA
Meetings with the MHRA can also be arranged to discuss:
- Pharmacovigilance
- Promotional material
- Recommendation on labeling or package leaflet changes
- Post-authorization measures
Pre-meeting submissions help to fasten the procedure by avoiding unnecessary ‘Request for Further Information’ documents. Before the meeting, applicants must provide the MHRA with a brief about their intentions to avoid unnecessary discussions (which is anticipated for ten (10) to fifteen (15) minutes). The timeline for the MHRA meetings is not more than ninety (90) minutes. The submission of all the supporting documents is mandatory for review.
On such interactions with the MHRA, there are a few misconceptions. Here we list the most common ones.
Misconception 1: Meetings with the MHRA are not conclusive
Setting up and attending a meeting with the MHRA can be tedious. Nevertheless, the MHRA and its staff ensure that a proper advice letter is sent to the applicant within fifteen (15) days, right after the applicant submits the meeting notes. In case of any confusion related to the advice stated in the letter, the applicant can ask for clarification. The MHRA takes care that the issues of the applicants are addressed responsibly in a written form. An applicant can request a joint scientific advice meeting with the MHRA and the National Institute for Healthcare and Excellence (NICE) to discuss an in-depth evaluation of Regulatory issues and health technology assessment. This meeting also offers an opportunity to discuss the evaluation of clinical study design, pharmacovigilance, advertising, labeling/PIL changes, and post-authorization measures that satisfy Regulatory and NICE requirements. A separate document addressing the issues raised is maintained.
Misconception 2: Meetings with the MHRA are product specific
MHRA offers relevant advice to the applicant depending on the need of the meeting/stage of development/nature of questions, where there would be two options for conducting a meeting - a specific scientific objective related to a product or a broader extensive objective not associated with one (01) product. In broader scope meetings, general issues related to product development, choice of study endpoints in a specific indication, the study design, its management, and analysis, as well as the Reference Medicinal Product (RMP) and permissible reclassification of the products, are discussed. The Regulatory questions of the medicinal product should also include concerns related to future development.
Misconception 3: Small and medium-sized enterprises are not eligible for meetings with the MHRA
Small or medium-sized enterprises can also request to schedule a meeting with the MHRA. However, to obtain the status of Small and Mid-sized Enterprise (SME), the company audit details needs to be attached along with the SME status application and submitted on the sales.invoices@mhra.gov.uk mail ID. If the requirements of the MHRA are met, the company must submit the scientific advice application. The SMEs are eligible for a certain easement concerning the payment of the meeting. For instance, for a new active substance, the applicant can pay twenty-five (25) % of the application fee at the time of application, and the remaining seventy-five (75) % can be paid once the MA is determined.
Misconception 4: The MHRA conducts only one development meeting/product/year
Applicants can have multiple meetings with the MHRA, unlike the FDA (which recommends only one development meeting/product/year), provided that further advice will be considered as a new request. Also, the scientific advice meeting decision provided in the MHRA letter is not final. Applicants still have the leverage to ask for clarification on scientific advice, provided which is carried out through email communication/teleconference.
Amid all these misconceptions, how are you planning to go ahead with the Health Authority interactions? A planned and structured approach to HA communication saves time, effort, and cost and helps fast-track applications and query resolution. For the best Regulatory support, contact Freyr now.
